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2. Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE

Author

Heller, S., Lingvay, I., Marso, S.P., Philis‐Tsimikas, A., Pieber, T.R., Poulter, N.R., Pratley, R.E., Hachmann‐Nielsen, E., Kvist, K., Lange, M., Moses, A.C., Andresen, M.T., and Buse, J.B.

Subjects
cardiovascular diseases
Abstract

Aims\ud \ud To undertake a post‐hoc analysis, utilizing a hypoglycaemia risk score based on DEVOTE trial data, to investigate if a high risk of severe hypoglycaemia was associated with an increased risk of cardiovascular events, and whether reduced rates of severe hypoglycaemia in patients identified as having the highest risk affected the risk of cardiovascular outcomes.\ud \ud \ud Materials and Methods\ud \ud The DEVOTE population was divided into quartiles according to patients' individual hypoglycaemia risk scores. For each quartile, the observed incidence and rate of severe hypoglycaemia, major adverse cardiovascular event (MACE) and all‐cause mortality were determined to investigate whether those with the highest risk of hypoglycaemia were also at the greatest risk of MACE and all‐cause mortality. In addition, treatment differences within each risk quartile [insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100)] in terms of severe hypoglycaemia, MACE and all‐cause mortality were investigated.\ud \ud \ud Results\ud \ud Patients with the highest risk scores had the highest rates of severe hypoglycaemia, MACE and all‐cause mortality. Treatment ratios between degludec and glargine U100 in the highest risk quartile were 95% confidence interval (CI) 0.56 (0.39; 0.80) (severe hypoglycaemia), 95% CI 0.76 (0.58; 0.99) (MACE) and 95% CI 0.77 (0.55; 1.07) (all‐cause mortality).\ud \ud \ud Conclusions\ud \ud The risk score demonstrated that a high risk of severe hypoglycaemia was associated with a high incidence of MACE and all‐cause mortality and that, in this high‐risk group, those treated with degludec had a lower incidence of MACE. These observations support the hypothesis that hypoglycaemia is a risk factor for cardiovascular events.

Published
2020

3. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes : the randomised, head-to-head CONCLUDE trial

Author

Philis-Tsimikas, A., Klonoff, D.C., Khunti, K., Bajaj, H.S., Leiter, L.A., Hansen, M.V., Troelsen, L.N., Ladelund, S., Heller, S., and Pieber, T.R.

Abstract

Aims/hypothesis\ud \ud A head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin.\ud \ud \ud \ud Methods\ud \ud This randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA1c ≤80 mmol/mol (9.5%) and BMI ≤45 kg/m2. Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0–5.0 mmol/l. Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [

Published
2020

4. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial

Author

LaRocque, J.C., Gross, J.L., Wallenstein, S.O.R., Bilz, S., Oğuz, A., Christiansen, E., El Hefnawy, M.H.M.F., Özdemir, A., Finneran, M.P., Rista, L., Akın, S., O'Connor, T.M., Gulseth, H.L., Kim, N.H., Lederman, S.N., Mertens, A., Arif, A.A., Nicol, P.R., Ong, S., Aronne, L.J., Sorli, C.H., Winnie, M., Fließer-Görzer, E., Tetiker, T., Pieber, T., Condit, J., Eagerton, D.C., Murray, A.V., Weiss, D., Aladağ, N., Litchfield, W.R., Cooper, J., Riffer, E., Colin, I., Prager, R., Beckett, P.L., Baik, S.H., Scheen, A., Godbole, N.A., Bays, H., Cho, Y.M., White, A., Fischli, S., Kang, E.S., Lee, K.-W., Weinstein, D.L., Shelbaya, S.A., Chung, C.H., Rudofsky, G., Laimer, M., Sivalingam, K., Wium, C., Pereles-Ortiz, J., PIONEER 7 investigators, Seo, J.A., Buse, J.B., Warren, M.L., Palchick, B.A., Delgado, B., Ataoglu, E., Khalil, S.H.A., Streja, D.A., Eliaschewitz, F.G., Golay, A., Høivik, H.O., Helland, F., Gorban de Lapertosa, S., Sarı, R., T'Sjoen, G., Van Gaal, L., Vercammen, C., Pieber, T.R., Hertz, C.L., Morawski, E.J., Kim, I.J., Stäuble, S., Issa, C., Geohas, J., Canani, L.H.S., Klaff, L.J., Manning, M.B., Bode, B., Yavuz, D., Preumont, V., Schultes, B., Aronoff, S., Palace, E.M., El Ebrashy, I.N., Keller, C., Berker, D., and Braun, E.W.

Abstract

Background: Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg. Methods: In this 52-week, multicentre, randomised, open-label, phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA1c of 7·5–9·5% (58–80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily. To approximate treatment individualisation in clinical practice, oral semaglutide dose could be adjusted on the basis of prespecified HbA1c and tolerability criteria. Two efficacy-related estimands were prespecified: treatment policy (regardless of treatment discontinuation or use of rescue medication) and trial product (on treatment and without use of rescue medication) for participants randomly assigned to treatment. The primary endpoint was achievement of HbA1c of less than 7% (53 mmol/mol) at week 52 and the confirmatory secondary efficacy endpoint was change in bodyweight from baseline to week 52. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02849080, and European Clinical Trials Database, EudraCT number 2015-005593-38, and an open-label extension is ongoing. Findings: Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251). Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9). All participants were given at least one dose of their allocated study drug except for one participant in the sitagliptin group. From a mean baseline HbA1c of 8·3% (SD 0·6%; 67 mmol/mol [SD 6·4]), a greater proportion of participants achieved an HbA1c of less than 7% with oral semaglutide than did with sitagliptin (treatment policy estimand: 58% [134 of 230] vs 25% [60 of 238]; and trial product estimand: 63% [123 of 196] vs 28% [52 of 184]). The odds of achieving an HbA1c of less than 7% was significantly better with oral semaglutide than sitagliptin (treatment policy estimand: odds ratio [OR] 4·40, 95% CI 2·89–6·70, p

Published
2019
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5. The effect of basal-bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis

Author

Heller, S., Bowering, K., Raskin, P., Liebl, A., Buchholtz, K., Gorst-Rasmussen, A., and Pieber, T.R.

Abstract

Aims\ud To investigate the impact of baseline 1,5-anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes. \ud Methods\ud Post hoc analysis of onset 3, an 18-week, randomized, phase 3 trial evaluating the efficacy and safety of fast-acting insulin aspart in basal–bolus therapy (n\ud =116) vs. basal insulin-only therapy (n=120) in people with Type 2\ud diabetes. The estimated treatment difference in change from baseline in HbA\ud 1c was investigated for different cut-off values of baseline 1,5-anhydroglucitol (2, 3, 4, 5 and 6 μg/ml). \ud Results\ud The estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin‐only therapy was statistically significantly greater in participants with baseline 1,5‐anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95% CI): −1.53% (−2.12; −0.94) vs. −0.82% (−1.07; −0.57); P‐value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5‐anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95% CI): −2.26% (−3.15; −1.36) vs. −0.85% (−1.08; −0.62); P‐value for interaction = 0.003]. For cut‐off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut‐off compared with above, although the interaction terms were not statistically significant.\ud Conclusion\ud This analysis indicates that people with Type 2 diabetes with low 1,5‐anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5‐anhydroglucitol. Further research is needed to clarify any clinical utility of these findings.\ud Clinical Trials Registry No: NCT01850615

Published
2018

6. Pharmacokinetic Properties of Liraglutide as Adjunct to Insulin in Subjects with Type 1 Diabetes Mellitus

Author

Mader, J.K., Jensen, L., Ingwersen, S.H., Christiansen, E., Heller, S., and Pieber, T.R.

Subjects
endocrine system diseases, nutritional and metabolic diseases
Abstract

BACKGROUND: The pharmacokinetic properties of liraglutide, a glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes mellitus (T2D), have been established in healthy individuals and subjects with T2D. Liraglutide has been under investigation as adjunct treatment to insulin in type 1 diabetes mellitus (T1D). This single-center, double-blind, placebo-controlled, crossover, clinical pharmacology trial is the first to analyze the pharmacokinetic properties of liraglutide as add-on to insulin in T1D. METHODS: Subjects (18-64 years; body mass index 20.0-28.0 kg/m(2); glycated hemoglobin ≤9.5 %) were randomized 1:1:1 to 0.6, 1.2, or 1.8 mg liraglutide/placebo. Each group underwent two 4-week treatment periods (liraglutide then placebo or placebo then liraglutide) separated by a 2- to 3-week washout. Both trial drugs were administered subcutaneously, once daily, as adjunct to insulin. A stepwise hypoglycemic clamp was performed at the end of each treatment period (data reported previously). Pharmacokinetic endpoints were derived from liraglutide concentration-time curves after the final dose and exposure was compared with data from previous trials in healthy volunteers and subjects with T2D. RESULTS: The pharmacokinetic properties of liraglutide in T1D were comparable with those observed in healthy volunteers and subjects with T2D. Area under the steady-state concentration-time curve (AUC) and maximum plasma concentration data were consistent with dose proportionality of liraglutide. Comparison of dose-normalized liraglutide AUC suggested that exposure in T1D, when administered with insulin, is comparable with that observed in T2D. CONCLUSIONS: Liraglutide, administered as adjunct to insulin in subjects with T1D, shows comparable pharmacokinetics to those in subjects with T2D. ClinicalTrials.gov Identifier: NCT01536665.

Published
2016

7. 7th Framework Program - Funded EHealth systems for diabetes

Author

Kardas, P., Beck, P., Bromuri, S., Chiarugi, F., Enzmann, M., Höll, B., Keller, O., Lane, S., Mader, J., Marchesini, O., Mougiakakou, S., Neubauer, K., Pieber, T.R., Plößnig, M., Puricel, S.G., Schaupp, L., Spat, S., and Publica

Published
2014

8. Exome sequencing identifies a REEP1 mutation involved in distal hereditary motor neuropathy type V

Author

Beetz, C., Pieber, T.R., Hertel, N., Schabhüttl, M., Fischer, C., Trajanoski, S., Graf, E., Keiner, S., Kurth, I., Wieland, T., Varga, R.-E., Timmerman, V., Reilly, M.M., Strom, T.M., and Auer-Grumbach, M.

Subjects
Male, Report, Mutation, Humans, Membrane Transport Proteins, Peripheral Nervous System Diseases, Exome, Female, Sequence Analysis, DNA, Cell Line, Pedigree
Abstract

The distal hereditary motor neuropathies (dHMNs) are a heterogeneous group of neurodegenerative disorders affecting the lower motoneuron. In a family with both autosomal-dominant dHMN and dHMN type V (dHMN/dHMN-V) present in three generations, we excluded mutations in all genes known to be associated with a dHMN phenotype through Sanger sequencing and defined three potential loci through linkage analysis. Whole-exome sequencing of two affected individuals revealed a single candidate variant within the linking regions, i.e., a splice-site alteration in REEP1 (c.304-2A>G). A minigene assay confirmed complete loss of splice-acceptor functionality and skipping of the in-frame exon 5. The resulting mRNA is predicted to be expressed at normal levels and to encode an internally shortened protein (p.102_139del). Loss-of-function REEP1 mutations have previously been identified in dominant hereditary spastic paraplegia (HSP), a disease associated with upper-motoneuron pathology. Consistent with our clinical-genetic data, we show that REEP1 is strongly expressed in the lower motoneurons as well. Upon exogeneous overexpression in cell lines we observe a subcellular localization defect for p.102_139del that differs from that observed for the known HSP-associated missense mutation c.59C>A (p.Ala20Glu). Moreover, we show that p.102_139del, but not p.Ala20Glu, recruits atlastin-1, i.e., one of the REEP1 binding partners, to the altered sites of localization. These data corroborate the loss-of-function nature of REEP1 mutations in HSP and suggest that a different mechanism applies in REEP1-associated dHMN.

Published
2012

10. Vitamin D, cardiovascular disease and mortality

Author

Pilz, S., Tomaschitz, A., Marz, W., Drechsler, C., Ritz, E., Zittermann, A., Cavalier, E., Pieber, T.R., Lappe, J.M., Grant, W.B., Holick, M.F., Dekker, J.M., Epidemiology and Data Science, and EMGO - Lifestyle, overweight and diabetes

Published
2011
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12. Further evidence for genetic heterogeneity of distal HMN type V, CMT2 with predominant hand involvement and Silver syndrome

Author

Rohkamm, B., Reilly, M.M., Lochmüller, Hanns, Schlotter-Weigel, B., Barišić, Nina, Schöls, L., Nicholson, G., Pareyson, D., Laur&#224, Janecke, A.R., Miltenberger-Miltenyi, G., John, E., Fischer, C., Grill, F., Wakeling, W., Davis, M., Pieber, T.R., and Auer-Grumbach, Michaela

Subjects
HMN V, CMT 2, genetics, Charcot-marie-tooth disease type 2d. Cmt2, Distal hereditary motor neuropathy, Dhmn, Bscl2, Gars, Hspb1, Hspb8
Abstract

OBJECTIVE: Distal hereditary motor neuropathy type V (dHMN-V) and Charcot-Marie-Tooth syndrome (CMT) type 2 presenting with predominant hand involvement, also known as CMT2D and Silver syndrome (SS) are rare phenotypically overlapping diseases which can be caused by mutations in the Berardinelli-Seip Congenital Lipodystrophy 2 (BSCL2) and in the glycyl-tRNA synthetase encoding (GARS) genes. Mutations in the heat-shock proteins HSPB1 and HSPB8 can cause related distal hereditary motor neuropathies (dHMN) and are considered candidates for dHMN-V, CMT2, and SS. DESIGN: To define the frequency and distribution of mutations in the GARS, BSCL2, HSPB1 and HSPB8 genes we screened 33 unrelated sporadic and familial patients diagnosed as either dHMN-V, CMT2D or SS. Exon 3 of the BSCL2 gene was screened in further 69 individuals with an unclassified dHMN phenotype or diagnosed as hereditary spastic paraplegia (HSP) complicated by pure motor neuropathy. RESULTS: Four patients diagnosed with dHMN-V or SS carried known heterozygous BSCL2 mutations (N88S and S90L). In one dHMN-V patient we detected a putative GARS mutation (A57V). No mutations were detected in HSPB1 and HSPB8. The diagnostic yield gained in the series of 33 probands was 12% for BSCL2 mutations and 3% for GARS mutations. In the series of unclassified dHMN and complicated HSP cases no mutations were found. CONCLUSIONS: Our data confirm that most likely only two mutations (N88S, S90L) in exon 3 of BSCL2 may lead to dHMN-V or SS phenotypes. Mutations in GARS, HSPB1 and HSPB8. are not a common cause of dHMN-V, SS and CMT2D. We would therefore suggest that a genetic testing of dHMN-V and SS patients should begin with screening of exon 3 of the BSCL2 gene. Screening of the GARS gene is useful in patients with CMT2 with predominant hand involvement and dHMN-V. The rather low frequencies of BSCL2, GARS, HSPB1 and HSPB8 mutations in dHMN-V, CMT2D and SS patients strongly point to further genetic heterogeneity of these related disorders.

Published
2007

13. Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes

Author

Pieber, T.R., Eugene-Jolchine, I., Derobert, E., Wolffenbuttel, B.H.R., European Study Group of HOE, -901, Interne Geneeskunde, and RS: NUTRIM School of Nutrition and Translational Research in Metabolism

Subjects
Adult, Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Insulin, Isophane, Insulin analog, Insulin Glargine, NPH insulin, Hypoglycemia, Bedtime, Internal medicine, Internal Medicine, medicine, Humans, Insulin, Single-Blind Method, Aged, Advanced and Specialized Nursing, Glycated Hemoglobin, Type 1 diabetes, Insulin glargine, business.industry, Middle Aged, medicine.disease, Insulin, Long-Acting, Endocrinology, Diabetes Mellitus, Type 1, Regular insulin, Fructosamine, Female, Safety, business, medicine.drug
Abstract

OBJECTIVE: HOE 901 (Hoechst Marion Roussel, Frankfurt, Germany) is a biosynthetic insulin with a prolonged action. The aim of this study was to compare the effect of the long-acting insulin analog HOE 901 with NPH insulin regarding glycemic control in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 333 type 1 diabetic patients were enrolled in this multinational parallel group trial. Subjects were randomized either to two different formulations of HOE 901 (the formulations differed only in zinc content) or to NPH insulin. The study was only partially blinded because patients can distinguish HOE 901 (a clear solution) from NPH (a cloudy suspension). In addition to premeal injections of regular insulin, patients received HOE 901 at bedtime or NPH once daily at bedtime or twice daily in the morning and at bedtime. RESULTS: Fasting plasma glucose levels were significantly lower with HOE 901 (-1.88 mmol/l. P = 0.0005) as were fasting self-monitored blood glucose levels (-0.80 mmol/l, P = 0.0020). HbA1c levels also showed a significant reduction with HOE 901 (-0.14%) versus NPH (P = 0.030). The overall frequency of hypoglycemia did not differ, but the frequency of nocturnal hypoglycemia was significantly (P = 0.0037) lower with HOE 901 (36 vs. 55%). However, this effect on nocturnal hypoglycemia was significant only versus NPH once daily not NPH twice daily. The pattern of adverse events and injection site reactions with HOE 901 was similar to that with NPH. CONCLUSIONS: This study indicates that HOE 901 achieves better control of fasting glucose and HbA1c levels over 4 weeks, and HOE 901 has a possible safety benefit in terms of nocturnal hypoglycemia.

Published
2000

14. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7)

Author

Franek, E., McGuire, D.K., Hansen, C.T., Zinman, B., Marso, S.P., DEVOTE Study Group, Mark, T., Emerson, S.S., Buse, J.B., Gilbert, M.P., Moses, A.C., Pratley, R.E., Pieber, T.R., and Hansen, M.V.

Subjects
3. Good health
Abstract

Aims: The aim of this study was to describe the risks of cardiovascular (CV) events and severe hypoglycaemia with insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) in patients with type 2 diabetes (T2D) aged 65 years or older. Materials and methods: A total of 7637 patients in the DEVOTE trial, a treat-to-target, randomized, double-blind trial evaluating the CV safety of degludec vs glargine U100, were divided into three age groups (50-64 years, n = 3682; 65-74 years, n = 3136; ≥75 years, n = 819). Outcomes by overall age group and randomized treatment differences were analysed for major adverse cardiovascular events (MACE), all-cause mortality, severe hypoglycaemia and serious adverse events (SAEs). Results: Patients with increasing age had higher risks of CV death, all-cause mortality and SAEs, and there were non-significant trends towards higher risks of MACE and severe hypoglycaemia. Treatment effects on the risk of MACE, all-cause mortality, severe hypoglycaemia and SAEs were consistent across age groups, based on the non-significant interactions between treatment and age with regard to these outcomes. Conclusions: There were higher risks of CV death, all-cause mortality and SAEs, and trends towards higher risks of MACE and severe hypoglycaemia with increasing age after adjusting for baseline differences. The effects across age groups of degludec vs glargine U100 on MACE, all-cause mortality and severe hypoglycaemia were comparable, suggesting that the risk of MACE, as well as all-cause mortality, is similar and the risk of severe hypoglycaemia is lower with degludec regardless of age. Evidence is conclusive only until 74 years of age.

15. Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia in Patients with Type 2 Diabetes: Secondary Analysis (DEVOTE 11)

Author

McGuire, D.K., Poulter, N.R., Pratley, R.E., Jia, T., Pop-Busui, R., Hansen, M.B., Amod, A., Pieber, T.R., Zinman, B., Buse, J.B., Mark, T., and The DEVOTE Study Group

Subjects
urologic and male genital diseases, female genital diseases and pregnancy complications, 3. Good health
Abstract

Introduction: The associations of chronic kidney disease (CKD) severity, cardiovascular disease (CVD), and insulin with the risks of major adverse cardiovascular events (MACE), mortality, and severe hypoglycemia in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk are not known. This secondary, pooled analysis of data from the DEVOTE trial examined whether baseline glomerular filtration rate (GFR) categories were associated with a higher risk of these outcomes. Methods: DEVOTE was a treat-to-target, double-blind trial involving 7637 patients with T2D at high CV risk who were randomized to once-daily treatment with either insulin degludec (degludec) or insulin glargine 100 units/mL (glargine U100). Patients with estimated GFR data at baseline (n = 7522) were analyzed following stratification into four GFR categories. Results: The risks of MACE, CV death, and all-cause mortality increased with worsening baseline GFR category (P < 0.05), with a trend towards higher rates of severe hypoglycemia. Patients with prior CVD, CKD (estimated GFR < 60 mL/min/m2), or both were at higher risk of MACE, CV death, and all-cause mortality. Only CKD was associated with a higher rate of severe hypoglycemia, and the risk of MACE was higher in patients with CVD than in those with CKD (P = 0.0003). There were no significant interactions between randomized treatment and GFR category. Conclusion: The risks of MACE, CV death, and all-cause mortality were higher with lower baseline GFR and with prior CVD, CKD, or both. The relative effects of degludec versus glargine U100 on outcomes were consistent across baseline GFR categories, suggesting that the lower rate of severe hypoglycemia associated with degludec use versus glargine U100 use was independent of baseline GFR category. Funding: Novo Nordisk.

16. Lower rates of cardiovascular events and mortality associated with liraglutide use in patients treated with basal insulin: A DEVOTE subanalysis (DEVOTE 10)

Author

Brown-Frandsen, K., Emerson, S.S., Pratley, R.E., Zinman, B., Lange, M., Pieber, T.R., McGuire, D.K., Poulter, N.R., Moses, A.C., Ranthe, M.F., Grøn, R., Örsy, P., DEVOTE Study Group, and Buse, J.B.

Subjects
3. Good health
Abstract

Aim: To compare the associations between concomitant liraglutide use versus no liraglutide use and the risk of major adverse cardiovascular events (MACE) and all-cause mortality among patients receiving basal insulin (either insulin degludec [degludec] or insulin glargine 100 units/mL [glargine U100]) in the Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE). Materials and Methods: Patients with type 2 diabetes and high cardiovascular risk were randomized 1:1 to degludec or glargine U100. Hazard ratios for MACE/mortality were calculated using a Cox regression model adjusted for treatment and time-varying liraglutide use at any time during the trial, without interaction. Sensitivity analyses were adjusted for baseline covariates including, but not limited to, age, sex, smoking and prior cardiovascular disease. Results: At baseline, 436/7637 (5.7%) patients were treated with liraglutide; after baseline, 187/7637 (2.4%) started and 210/7637 (2.7%) stopped liraglutide. Mean liraglutide exposure from randomization was 530.2 days. Liraglutide use versus no liraglutide use was associated with significantly lower hazard rates for MACE [0.62 (0.41; 0.92)95%CI] and all-cause mortality [0.50 (0.29; 0.88)95%CI]. There was no significant difference in the rate of severe hypoglycaemia with versus without liraglutide use. Multiple sensitivity analyses yielded similar results. Conclusions: Use of liraglutide was associated with significantly lower risk of MACE and death in patients with type 2 diabetes and high cardiovascular risk using basal insulin.

17. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes

Author

Marso, Steven P., McGuire, Darren K., Zinman, Bernard, Poulter, Neil R., Emerson, Scott S., Pieber, Thomas R., Pratley, Richard E., Haahr, Poul-Martin, Lange, Martin, Brown-Frandsen, Kirstine, Moses, Alan, Skibsted, Simon, Kvist, Kajsa, Buse, John B., Hansen, Liliana, Rabol, Rasmus, Bethel, Angelyn, de Lemos, James A., Senn, Stephen, Schwamm, Lee, Timmis, Adam, Alshekhlee, Amer, Bach, Richard G., Bertram, Therese M., Chaitman, Bernard R., Cruz-Flores, Salvador, Eckstein, Jane F., Feen, Eliahu S., Fisher, Simon J., Gosselin, Gilbert, Lim, Michael J., Rosenzweig, James L., Sherwin, Robert S., Tobin, Garry S., Vetrovec, George, Ziemer, David C., Daugaard, Gedske, Ozlem, Er, Pollak, Michael, Sengelov, Lisa, Ahn, Yu-Bae, Amod, Aslam, Benroubi, Mariana, Boonyavarakul, Apussanee, Canecki-Varzic, Silvija, Consoli, Agostino, Eliaschewitz, Freddy G., Franek, Edward, Jinnouchi, Hideaki, Khokhlov, Alexander L., Mithal, Ambrish, Philis-Tsimikas, Athena, Ong, Tiong Kiam, Pop, Lavinia, Reyna, Leobardo Sauque, Rodbard, Helena W., Roula, Daoud, Saravanan, Ponnusamy, Sesti, Giorgio, Sorli, Christopher, Sposetti, Georgina, Tinahones-Madueno, Francisco-Jose, Woo, Vincent, Berard, Lori, Caballero Mateos, Irene, Cooper, Alison, DeLuca, Clarisa, Fillary, Julie, Gan, Diyana Gan Abdul Rahman, Goondiwala, Amina, Tapia, Jessica, Busch, Robert, Chaykin, Louis, Hollander, Priscilla, Karounos, Dennis, Lane, Wendy, Lingvay, Ildiko, Odugbesan, A. Ola, Ohlson-Elliott, Theresa, Ovalle, Fernando, Pantalone, Kevin M., Phelps, Spencer, Pop-Busui, Rodica, Robertson, David, Shlesinger, Yshay, Silver, Robert, Warren, Mark, Arrar, Mohammed, Belkheir, Hassani, Benabbas, Youcef, Benferhat, Schahrazed, Benoun, Fatima, Bensalem, Samia, Bourezane, Samia, Elaoufi, Selmane Rafik, Gourine, Mouna, Hadjhabib, Mohamed, Hadjhamou, Fouzia, Hakem, Jamila, Kaouache, Nadjib, Khensal, Sabrina, Kitouni, Yacine, Lakhal, Lamine, Lezzar, Al-Kassem, Meftah, Imane Aicha, Mehenni, Lahouaria, Nouri, Nassim, Oumerzouk, Fatma, Sakouhi, Mounia, Talha, Kheira, Zemri, Zouaouia, Caeiro, Gabriela, Calveyra, Martha, Cluigt, Natalia, Geronazzo, Veronica, Lema, Silvina, Monferran, Pablo Martinez, Oviedo, Alejandra, Pozzi, Jose, Sala, Jorgelina, Schindler, Ana, Sernia, Virginia, Sicer, Maximiliano, Solis, Silvana, Varela, Patricia, Waitman, Jorge, Augusto, Gustavo Akerman, Alves, Breno, Alves, Erica, Barbosa, Luciana, Bona, Renata, Borges, Joao, Bosco, Adriana, Canani, Luis, Castro, Denise, Cavalcante, Lilian, Cechin, Laura, Cercato, Cintia, Chrisman, Carlos, Chrisman, Carolina, Cintra, Rebecca, Costa, Giselle, Fontenele, Ana Paula, Forti, Adriana, Francisco, Beatriz, Franco, Denise, Genestreti, Paulo, Gross, Jorge, Haddad, Ludmila, Halpern, Alfredo, Hissa, Miguel, Leanca, Camila, Leao, Beatriz, Marinho, Ana Elisabeth, Miranda, Isabela, Nunes, Adriano, Palhares, Fabiana, Poco, Christiani, Salles, Joao, Sampaio, Celia, Santomauro Jr., Augusto, Sartori, Carla, Sena, Rita, da Silva, Marina, da Silva, Paula, Siqueira, Katia, Turatti, Luiz, Valenti, Adriana, Vasques, Enio, Vencio, Sergio, Visconti, Guilherme, Belanger, Andre, Chilvers, Martyn, Dumas, Richard, Hurd, Carmen, Lafleche, Francois, Lam, Paul, Martinho, Valdemar, Palardy, Jean, Peterson, Sean, Raff, Errol, Sinnaeve, Linda, Sullivan, David, Baraban, Vedrana, Blaslov, Kristina, Bulum, Tomislav, Varzic, Silvija Canecki, Berkovic, Maja Cigrovski, Balen, Marica Jandric, Kruljac, Ivan, Lesnjakovic, Silvija, Lucijanic, Tomo, Majic, Ana, Rahelic, Dario, Smircic-Duvnjak, Lea, Vrkljan, Milan, Zibar, Karin, Zukanovic, Sidbela, Athanasopoulou, Elpida, Benis, Apostolos, Benroubi, Marian, Diakoumopoulou, Evanthia, Doupis, John, Griva, Theodora, Kazakos, Kyriakos, Kypraios, Nikolaos, Liatis, Stavros, Makrilakis, Konstantinos, Markou, Athina, Pagkalos, Emmanouil, Papanastasiou, Labrini, Piaditis, George, Sampanis, Christos, Siami, Evangelia, Tentolouris, Nikolaos, Tsiama, Vasiliki, Zografou, Ioanna, Adling, Pravishal, Ali, Mazher, Anjana, R. M., Arora, Arpita, Ayyar, Vageesh, Banerjee, Suvro, Bantwal, Ganapathi, Bhagwat, Nikhil, Bhattacharyya, Arpandev, Bhawarlal, Anandakumar, Chakraborty, Rabin, Chatterjee, Sanjay, Chaudhury, Tirthankar, Chowdhury, Subhankar, Damelia, Priyal, Das, Mrinal, Das, Sambit, Desai, Ankush, Devru, Nandani, Farooqui, Khalid, Ganie, Mohd Ashraf, George, Belinda, Ghosh, Debasis, Girithara, Gopalakrishnan, Haribhai, Zinzuwadia, Jain, Nupur, Jassar, Amandeep, Joshi, Ameya, Kale, Dilip, Kale, Shailaja, Kelwade, Jayant, Khatri, Ashok, Kulshreshtha, Bindu, Majumder, Bikas, Manikath, Neeraj, Margekar, Shubhalaxmi, Marwah, Tiven, Mathew, Vivek, Moulick, N. D., Mutha, Abhay, Muthu, Ramuu, Nalawade, Asmitha, Narvencar, Kedareshwar, Pandit, Kaushik, Pangtey, Ghanshyam, Parthasarathy, B., Phatak, Sanjeev, Prakash, Anupam, Prusty, Pitambar, Radhakrishnan, Chandni, Raja, Indu, Ravikumar, Ranjani, Saboo, Banshi, Sachdeva, Isha, Sangeetha, S., Selvam, Kasthuri, Sethi, Bipin, Shah, Asha, Shah, Harshal K., Shah, Priyanshu, Shah, Rushit, Shaikh, Sajid, Shaikh, Shehla, Singh, K. P., Sivagnanam, Nallaperumal, Tandon, Nikhil, Thonangi, Rajesh, Thulaseedharan, N., Toraskar, Kedar, Varthakavi, Premalatha, Yadav, Sameer, Andreozz, Francesco, Arturi, Franco, Baldassarre, Maria Pompea Antonia, Barone, Milena, Bonura, Alice, Bucciarelli, Loredana, Buscemi, Chiara, Buscemi, Silvio, Carnovale, Anna, Caselli, Chiara, Ceci, Gloria, Cimino, Elena, Colella, Alessandra, Crippa, Valentina, Cufone, Sabrina, D'Erasmo, Laura, De Remigis, Alessandra, Di Bartolo, Paolo, Dionisio, Rosa, Disoteo, Olga, Fabietti, Marcella, Febo, Fabrizio, Filetti, Sebastiano, Genovese, Stefano, Ginestra, Federica, Grancini, Valeria, Grieco, Elvira, Magistro, Andrea, Maranghi, Marianna, Monti, Lucilla, Orsi, Emanuela, Pellicano, Francesca, Pergolini, Daniela, Perticone, Francesca, Piatti, PierMarco, Pizzi, Gianluigi, Rondinelli, Maurizio, Rossi, Margherita, Rubino, Mariangela, Setola, Emanuela, Succurro, Elena, Tarquini, Giovanna, Tiseo, Giusy, Tonolo, Giancarlo, Villa, Valentina, Hong, Stefania Vo, Amano, Kazushi, Hachiya, Remi, Hieshima, Kunio, Hirao, Koichi, Hisatake, Tomoko, Honda, Ritsuko, Ihana, Noriko, Inoue, Kaori, Iwamoto, Yasuhiko, Jinnouchi, Tomio, Kajiwara, Keizou, Kawazu, Shoji, Kikuchi, Masatoshi, Kikuchi, Takako, Koike, Yoko, Komatsu, Mitsuhisa, Kumakura, Atsushi, Kurinami, Noboru, Kushiyama, Akifumi, Maeda, Hajime, Matsuda, Toshihisa, Nakamura, Shuji, Nakayama, Koujin, Nishio, Shin-ichi, Onishi, Yukiko, Sato, Nobuyuki, Sato, Yoshihiko, Shirabe, Shinichiro, Sugiyama, Seigo, Suzuki, Tomoko, Tahara, Tazu, Takao, Toshiko, Takei, Masahiro, Takemoto, Ikutaka, Takeshige, Keiko, Tanaka, Kentaro, Taniguchi, Shotaro, Tsujimoto, Tetsuro, Tsukuda, Katsunori, Wakabayashi, Sayaka, Yamazaki, Masanori, Yoshida, Yoko, Yoshimoto, Ayako, Abidin, Imran Zainal, Abdullah, Shahrin Tarmizi Che, Adam, Noor Lita, Ahmad, Madihah, Ahmad, Nik Nur Fatnoon Nik, Amin, Nor Hanim Mohd, Aw, Cheng Yew, Cham, Yee Ling, Chong, Hui Min, Chua, Seng Keong, Fauzi, Sharifah Aisyah Shahabudin Syed Ahmad, Fong, Alan Yean Yip, Ghapar, Abd Kahar Abd, Hanafi, Norliza, Abu Hassan, Muhammad Radzi, Iberahim, Rahimah, Khiew, Ning Zan, Lee, Gary Chin Keong, Lingam, Rakesh, Long, Richard Chay Shien, Mahendran, Kauthaman A., Oon, Yen Yee, Said, Asri, Sothiratnam, Radhakrishna, Sridhar, Ganiga Srinivasiah, Suan, Mohd Azri Mohd, Tan, Sian Kong, Tey, Julian Hock Chuan, Undok, Abdul Wahab, Waid, Anuar, Vijayasingham, Shalini, Voon, Chi Yen, Yew, Kuan Leong, Yong, Lit Sin, Aguilar-Parra, Lilia, Aguirre, Karen, Alvarez-Carrillo, Rebeca, Arechavaleta-Granell, Maria, Baez-Campos, Aurelia, Bayram Llamas, Edmundo Alfredo, Calvo-Vargas, Cesar, Cedano-Limon, Marielena, Beltran Jaramillo, Teresita de Jesus, de Jesus Marin-Lopez, Jose, Ruiz Cornejo, Maria de Jesus, Juarez Cervantes, Maria del Carmen, Estevez de Alba, Isabel, Estrada Garcia, Raul, Estrada, Suellen, Garza-Vergara, Marisol, Gonzalez-Perez, Rosa, Gonzalez-Valencia, Carlos, Guerrero-Reyes, Rosalinda, Haro Ortiz, Jose Alfredo, Hernandez Salazar, Eduardo, Illescas Diaz, Iris, Illescas Diaz, Jesus, Loredo, Imelda, Jimenez-Ramos, Silvia, Larios-Mora, Diana, Lopez Garcia, Maria Elena, Lopez-Serrano, Julieta, Martinez-Nolasco, Bertha, Nunez Marquez, Ricardo, Pacheco Aranda, Elizabeth, Peralta-Cantu, Irving, Perez Chagollan, Ana, Ramirez, Maria, Robledo Duron, Israel, Rodriguez Briones, Ignacio, Rodriguez, Maria, Sauque Reyna, Leobardo, Vazquez-Ceja, Adriana, Vera-Bocanegra, Alejandro, Vidrio Velazquez, Maricela, Contreras Sandoval, Aleida Yael, Bartelik, Karol, Bilska, Aleksandra, Biniszkiewicz, Tomasz, Bogdanski, Pawel, Chamienia, Agnieszka, Cieslak-Puchalska, Anna, Czochra, Wojciech, Gajewski, Bogdan, Gromniak, Elwira, Holda, Ewa, Jaskulska-Gorzelewska, Barbara, Jedynasty, Krystyna, Kloda, Elzbieta, Kmak-Balawender, Beata, Kobielusz-Gembala, Iwona, Konieczny, Marek, Kramarczuk, Elzbieta, Kuleta, Jerzy, Lesniewski, Robert, Lominska, Teresa, Lukaszewicz, Monika, Majewska, Izabella, Mlynarski, Tomasz, Mostowy, Aleksandra, Rybak, Anna, Skrypnik, Damian, Wolny, Malgorzata, Zmuda, Witold, Buduru, Alina Nicoleta, Cif, Adriana, Cozma, Mihaela, Crisan, Carmen, Barbonta, Cristian Gelu, Barbonta, Diana, Mihalcea, Madalina, Mociran, Mihaela, Muresan, Sorina, Popescu, Alexandrina, Pruna, Luchiana, Sandu, Nadia Ramona, Suleac, Oana Andreea, Vincze, Eva Cornelia, Andreeva, Elena, Berns, Svetlana, Barykina, Irina, Bernitcyna, Angela, Bezdenezhnykh, Natalia, Chumachek, Elena, Demarina, Svetlana, Didenko, Anna, Dubinina, Nadezhda, Dzherieva, Irina, Elsukova, Olga, Esenyan, Lev, Filippova, Ekaterina, Gabova, Nadezhda, Garina, Irina, Glikman, Yulia, Glova, Svetlana, Goncharova, Ekaterina, Gorbatova, Elena, Gordeev, Ivan, Grigorian, Inessa, Gromova, Svetlana, Ipatko, Irina, Karaban, Elena, Katushkina, Yulia, Kaygorodtseva, Olga, Kerova, Irina, Khaisheva, Larisa, Khmelnitskiy, Oleg, Khokhlov, Alexander, Khokhlov, Mikhail, Khorolets, Ekaterina, Klyuenkova, Elena, Konovalova, Olga, Korneva, Ksenia, Kosmacheva, Elena, Kunitsyna, Marina, Kupriyanova, Tatiana, Kuznetsova, Natalia, Lantseva, Olga, Ledyaeva, Alla, Lileeva, Elena, Markovich, Alexander, Martirosian, Narine, Maslova, Alisa, Milyukova, Galina, Mokhova, Irina, Nagirniak, Olga, Nastina, Elena, Nedogoda, Sergei, Orlova, Valeriia, Svetlana, Otarova, Ostapenko, Marina, Papaskiri, Nino, Pavlikova, Elena, Peskov, Andrey, Petrik, Galina, Petrov, Alexander, Petunina, Nina, Platonov, Dmitry, Poliakova, Yulia, Potapova, Zhanna, Pribylova, Svetlana, Razumovsky, Igor, Redkin, Alexander, Rodionova, Tatyana, Rudenko, Evgenia, Rykalina, Natalia, Salasyuk, Alla, Semikina, Tatiana, Serebryakova, Inna, Shanina, Larisa, Shmidt, Evgenia, Sinitsina, Olga, Smetanina, Svetlana, Smirnova, Marya, Smirnova, Victoria, Smolentseva, Nadezhda, Sobolev, Alexander, Soldatenkova, Anna, Soldatova, Yulia, Speshilova, Svetlana, Startseva, Olga, Strezhova, Larisa, Strongin, Leonid, Suplotova, Lyudmila, Suvorova, Daria, Tepaeva, Alisa, Trukhina, Liubov, Tyugaeva, Alisa, Vasyutkova, Olga, Vinokurova, Valentina, Yukhno, Elena, Yuzhakova, Natalia, Zagrebelnaya, Olga, Zalevskaya, Alsu, Zhukova, Elena, Aomar Millan, Ismael, Beltran Romero, Luis M., Ignacio Fernandez Navarro, Jose, Carlos Ferrer Garcia, Juan, Garcia Blasco, Lourdes, Garcia Garcia, Clara, Garcia Puig, Juan, Girbes Borras, Juan, Inigo Zaera, Pilar, Lopez de la Torre, Mart-n, Martinez Alfaro, Baldomera, Morales Portillo, Cristobal, Romero Sanchez, Paloma, Sebastian Ochoa, Nerea, Serrano Olmedo, Isabel, Tinahones Madueno, Francisco, Torres Jimenez, Rosa, Adeyemo, A. O., Bassa, Ayesha, Bhorat, A., Bhorat, Qasim, Blacking, Laura, Burgess, Lesley, Coetzee, Kathleen, Conradie, Hillet, Cyster, Henry, Distiller, Larry, Ellis, G. C., Gani, Mashra, Gordon, Debra, Govender, Parimala, Govender, Thirumani, Govender, Vimladhevi, Jivan, Daksha, Joffe, Barry, Jooma, Yaseer, Kaplan, Hilton, Komati, Stephanus, Kramer, Brian, Kruger, Sieglinde, Landau, Stanley, Latiff, Gulam, Maritz, L., Matthews, Peter, Middlemost, S. J., Ngcakani, Nomangesi, Nortje, Hennie, Osman, Yasmin, Padayachee, Trevenesan, Podgorski, Gracjan, Potts, Jenny, Pretorius, Catharina, Prozesky, Hans, Snyman, Hans, Tayob, Mohammed, Urbach, Dorothea, van der Merwe, Maryke, Vorajee, Haroon, Wilson, Nadine, Wing, J. R., Lee, Jie Eun, Ahn, Chang Ho, Kim, Nam Hoon, Kim, Sun Hwa, Hwangbo, Yul, Ko, Sun Hye, An, Jee Hyun, Ko, Seung Hyun, Lee, Ji Hyun, Noh, Jung Hyun, Ji, Myeong Jin, Kim, Kyeong Jin, Jung, Chan-Hyeon, Kim, DongJun, Kim, Kyongyoung, Kim, Lee-Kyung, Kim, SinGon, Kim, Eun Ky, Lee, Dong-Hwa, Cho, Young Min, Moon, Shin-Je, Oh, Chang-Myung, Hong, A. Ram, Park, Kyeong Seon, Yun, Jae Seung, Hong, Jae Won, Kim, Hee Young, Buranapin, Supawan, Deerochanawong, Chaicharn, Hengjeerajarus, Natavuth, Kosachunhanun, Natapong, Kuanprasert, Srun, Kunavisarut, Tada, Laortanakul, Rungnapa, Mangklabruks, Ampica, Phornphutkul, Mattabhorn, Prasitdamrong, Hutsaya, Snabboon, Thiti, Sriwijitkamol, Apiradee, Suwanwalaikorn, Sompongse, Tantiwong, Puntip, Tejavanija, Sirakarn, Vorasettakarnkit, Yongkasem, Alasabbagh, Samer, Bagais, Christos, Bingley, Polly, Borthwick, Les, Brett, Barbara, Davidson, Sue, Ewing, Jane, Garesse, Robert, Gillani, Syed, Gkastaris, Konstantinos, Herring, Roselle, Illsley, Graham, Johnson, Andrew, Kaplan, Felicity, Lonnen, Kathryn, Malcolm, Ellen, McCrimmon, Rory, Mcknight, John, Nair, Rajiv, Patel, Vinod, Pearson, Ewan, Raghavan, Rajeev, Raj, Suchitra, Russell-Jones, David, Sampson, Mike, Singh, Baldev, Sukamer, Nithya, Turner, Jeremy, Venkataraman, Hema, Viljoen, Adie, Wake, Deborah, Barnes, Cassandra, Boyd, Gary, Childress, Gwen, Coleman, Debora, Combs, Judy, Davis, Leon, Davison, Kentress, DeAtkine, David, Dunaway, Linda, Duncan, Janet, Hibbard, Nina, Martin, Melissa, Nichols, Melissa, Painter, Karolynn, Perkins, Tammy, Quinney, Rosylen, Raymond, Katrina, Roney, Christopher, Sanchez, Gilberto, Sosnowchik, James, Sultan, Farah, Talley, Shellie, Trippe, Bruce, Tuck, Pamela, Vaughan, T., Warriner, Amy, Watts, Tamara, Williams, Hayes, Abidov, Aiden, Abidov, Yulia, Anderson, Corey, Avila, Vanessa, Baraniak, James, Berry, Barbara, Bessette, Lynn, Blackwell, Gina, Burrows, Jennifer, Caldron, Meghan, Chang, Chui-An, Collins, Elizabeth, Crawford, Meli'sa, Delfin, Katherine, De'Loera, Jessie, Dokken, Betsy, Feld, Lawrence, Gill, Ryan, Gordon, James, Gordon, Rachel, Gullick, Nicole, Gutierrez, Diane, Harrison, Larissa, Haught, Annamarie, Hemmila, Karin, Hendrickson, Darell, Horsley, Craig, Hsu, Connie, Jerrell, Maggie, Kertesz, Briana, Khananisho, Paulina, Lenzmeier, Sonia, Lenzmeier, Thomas, Lipschitz, Barbara, Lonquist, Mark, Mather, Dana, (Shelley) Miceli, Michelene, Norris, Gwenth, Padilla, Ann Marie, Petersen, Dena, Riffer, Ernie, Scott, Susan, Sheridan, Kathryn, Smith, Misty, Stump, Craig, Thomson, Stephen, Torok, Ernese, Vesely, Kelly, Vincent, Tom, Wilson, Christy, Wilson, Sandra, Agarwal, Monica, Appleberry, Kady, Barden, M. Gregg, Brickell, Lorrie, Bravo, Eric, Cassis, Cady, Covington, Becky, Devine, De'Andrea, Dishongh, Katherine, Dugger, Joseph, Evans, Lauren, Francis, Spencer, Johnson, David, Koneru, Kalyana, Kurck, Sheryl, Lingisetty, Chandra, Menke, Jennifer, Miller, Beatrice, Montgomery, Cristal, Nimmo, Teresa, Pace, Daniel, Pellegrino, Richard, Rose, Joseph, Straub, Karl, Stubbs, Amanda, Thomas, Leslie, Thrasher, James, Thrasher, Lesa, Wijewardane, Priyantha, Williamson, Kimberly, Acevedo, Lizeth, Ahmad, Aakif, Andresen, Teri, Anderson-Berman, Nancy, Ayele, Etsegenet, Baker, Janice, Banares, Arlene, Barsalou, Thea, Becker, Steven, Benavidez, JoAnn, Benitez, Guadalupe, Bernstein, Richard, Bhasker, Kala, Blain, Arthur, Blustin, Joy, Bughi, Stephanie, Carney, Kimberly, Castro, Gerardo, Catangay, Jennifer, Chambers, Joseph, Chan, Eve, Chang, Amy, Chang, Anna, Chavous Jr., Donald, Chen, Constance, Chiu, Ken, Chochinov, Ronald, Chu, James, Cleghorn, Monica, Cohen-Gadol, Shariar, Cokely, David, Collins, Michelle, Collins, Yolanda, Colomy, Carissa, Cruz-Corona, Yolanda, Cunnea, Virginia, Dailey, George, Dang, Andy, Dang, Trinh, De La Luz, Mabel, Delgadillo, Rico, Delgado, Michael, Desta, Taddese, Doriguzzi, David, Dulgeroff, Anthony, Einhorn, Daniel, Emery, Pamela, Figueroa, Martin, Fink, Raymond, Flowe, Chelsea, Flowers, Francesca, Fregosi, Julie, Garcia, Gabriel, Garcia, Maria, Gaudiani, Linda, Gawad, Michael, Ghattas, Sam, Gilroy, Christine, Gonzalez, Viviana, Gonzalez, Yadira, Guadron-Hernandez, Liliana, Ha, Thu, Haas, Terry, Harbison, Judy, Hernandez, Graciela, Hernandez, Robert, Herrera, Nancy, Ho, Vincent, Hsu, Kang, Humphries, Denise, Huynh, Vincent, Jacobs, Shahram, Jardula, Michael, Jarman, Cheryl, Kabongo, Martin, Kafri, Hassan, Kaplan, Roy, Kim, Grace, Kobayashi, Gary, Korff, Gary, Kowalick, Alexandra, Levin, Ellis, Lewis, Erin, Lisovskiy, Svetlana, Luu, Hieu, Malkhassian, Daniel, Maletz, Louis, Martinez, Geraldine, Martinez, Gilbert, Martinez-Miss, Salomon, McCallum, James, Melikian, George, Metcalf, Francine, Michlin, Bernard, Michlin, Shira, Mitchell, Anitha, Moattari, Ali Reza, Montano-Pereira, Cynthia, Moon, Mia, Naderi, Bahar, Nagata, Jenna, Nguyen, Christopher, Norwood, Paul, Garcia, Sagrario Olmos, Olsen, Sharon, Pardino, Aarika, Parkes, Kathleen, Pascal, Aileen, Patel, Mihir, Paulson, Carolyn, Pernia, Kay, Perez, Marisol, Pham, David, Presant, Larry, Preston, Krista, Reeves, Laurie, Richards, Jessica, Rios-Santiago, Jessica, Risser, Joseph, Rodriguez, Silvia, (Cherrie) Rosal, Rosario, Rosenblit, Paul, Rosero, Raquel, Sadler, Chris, Samoa, Raynald, Sanchez, Liliana, Schaeffer, Cynthia, Schwartz, Alan, Scott, Christopher, Scott, Courtney, Scott, Cranford, Shartel, Jo-Ann, Shaw, Sylvia, Sivalingam, Kanagaratnam, Sligh, Scott, Sligh, Teresa, Smith, Bradley, Soler, Daniel, Spencer, Torre, Stalters, Sophia, Stone, Jenine, Szlachcic, Yaga, Thorsell, Ashley, Tu, Zhongheng, Unger, Jeffrey, Vela, Teresa, Walton, Anita, Whittle, Jessica, Wilson, Lou Ellen, Wing, Zandra, Wright, Philippa, Wyman, Shannan, Yao, Ni, Zlock, Douglas, Baker, Chelsea, Bakkum, Robyn, Bird, C. David, Carangi, Gwen, Cohen, Kenneth, Daza-Taylor, Kristen, Diesburg-Stanwood, Amy, Douglass, Sara, Finck, Lani, Karaboitis, Krisoula, Kerstein, Howard, Lesh, Kurt, Loesch, Ryan, McClure, Lori, Nevarez, Max, Pavol, Bristol, Rasouli, Neda, Rockler, Briana, Sanagorski, Rebecca, Solano, Royce, Underkofler, Chantal, Van Winkle, Rebecca, Weiss, Sarah, White, Katherine, Wirtemburg, Patricia, Zarrabi, Lida, Zemel, Leonard, Barchini, George, Casagni, Kimberely, Cordisco, Marie Elena, Davis, Amanda, Duffy-Hidalgo, Bobbi, Huntley, Richard, McNicol, Donald, Miller, Neil, Mukwaya, Margaret, Northrup, Patricia, Platt, Jonathan, Rabideau, Diane, Randolph, Pamela, Rose, Suzanne, Samuel, James, Savino, Robert, Soufer, Joseph, Torello, Carole, Abinader, Azarel, Agosto, Milagos, Aguirre, Frank, Alexander, Lori, Almanza, Orlando, Alvarez, Dalia, Anees, Muhammad, Aqua, Keith, Arazo, Luz, Asberry, Claudia, Ashley, Alyssa, Balentine, Tracy, Barta, Melissa, Bertot, Ivan, Binns-Leon, Michelle, Borello, Nora, Bostick, Janette, Boucher, Loria, Braddy, Dalton, Breton, Cristian, Broxton, Bridgitte, Burke, Deborah, Cabielles, Tania, Calderon, Juan, Canaan, Yamil, Canelon, Gustavo, Cardona, Jose, Castillo-Gonzalez, Sheila, Castro, Kenia, Chacon, Jessica, Chehade, Joe, Church, Lara, Cohen, Lisa, Crews, Erin, Cromer, Carol, Cromer, Michael, Cuello, Jorge, Cusi, Kenneth, de Leon, Karel, Delgado, Edmund, Delima, Selma, Denson, Janneral, DeVries, Benjamin, Diaz, Maritza, Digon, Beningo, Dowell, Michelle, Dunn, Kelly, Ellington, Dickson, Emerick, George, Encarnacion, Frances, Ezell, Leslie, Fahmie, Ashley, Fernandez, Noel, Figueredo, Rommel, Flores, Patricia, Fonseca, Juan, Freeman, Alain, Freeman, Erica, Frias, Juan, Garcia, Lazaro, Geronilla, Giovanni, Hamilton, Maxine, Hanabergh, Rodolfo, Hanson, Lenita, Harris, Kim, Hasan, Syed, Hendrick, Mary, Hicks, Melissa, Hoffman, Lara, Holt, Antoniwa, Hutchinson, Rachel, Iparraguirre, Harold, Janicka, Ania, Janovitz, Richard, Jones, Dawn, Jones, Sarah, Kaplun, Polina, Kelijman, Mirtha, Kersey, Angela, Khan, Ashraf, Khan, Misal, Kirk, Gregory, Konwai, Ada, Kovar, Meghan, Kutner, Mark, Lafaille, Jimmy, Leach, Dana, Levenson, David, Lewy-Alterbaum, Lorena, Light, Timothy, Lo, Margaret, Loman, Lusiana, Long, Sarah, Love, Jeremy, Madera, Arelis, Magee, James, Mallitz, Michelle, Marquez, Farid, Marshall, Richard, Mary, James, Mateu, Janet, McKenzie, Leanna, McKenzie, Rona, McKenzie, Wilfred, Mendelson, Reina, Mendez, Janet, Merlos, Ledis, Mierau, Jennifer, Miller, Robert, Miranda-Palma, Bresta, Montoya, Carla, Navarro, Eduardo, Neller, Christian, Nossa, Janette, Osborn, Tracey, Patel, Bijal, Penabad, Jesus, Perez, Gilberto, Pineda, Daniel, Pinero-Pilona, Antonio, Platt, George, Prestwood, Elfrida, Quintero, Luis, Rengifo, Rodney, Reyes, Dannier, Rivas, Aolani, Rivero, Mileydis, Robinson, Sonya, Robison, Dawn, Rodriguez, Dalier, Rodriguez, Ivete, Rodriguez, Toni, Rosario, Cristobal, Rosenwasser, Rebecca, Roura, Miguel, Schramm, Erich, Schramm, Rashi, Schweppe, Laurie, Segel, Scott, Sepulveda, Maria, Sheets, Lori, Shields, Karen, Smith, Krystal, Smith, Meridith, Somerstein, Claudia, Solano, Maria, Suarez, Manuel, Suarez, Omar, Suarez, Rogelio, Suarez, Victor, Sultan, Senan, Sutton, David, Szilagyi, Istvan, Thorne, Margaret, Travaglini, Stefano, Trevino, Miguel, Uriarte, Oscar, Vizcaino, Luis, Wadud, Khurram, Wehmeier, Kent, Weinstein, Debra, Welch, Celeste, White, Alexander, White, Basil, Williams, Tammy, Williamson, Cathi, Zwick, Lisa, Adams, Cynthia, Arkin, David, Bode, Bruce, Bonner, Sheila, Bonner, Wes, Bowen, Danielle, Bradley, Brooke, Bradley, Paul, Brennan, Elizaebeth, Brown, Cynthia, Brown, De'Aira, Burgess, Elizabeth, Collett, Taryn, Cook, Jennifer, Corse, Steven, Dukes, Kaitlyn, Durrence, Jenna, Dutton, Robin, Estes, Susie, Falcone, Laura, Gaskin, Katherine, Goswami, Ketan, Hart, Mari, Jester, Donni, Kies, Staci, Leiker, Abigail, Lu, Peter, Mahakala, Aparna, Maher, Maxine, Miller, Alan, Miller, Todd, Munoz, Miguel, Musto, Michele, Odugbesan, Adeniyi, Olson, Darin, Osborn, Nicole, Pace, Kerri, Pajkovic, Gordana, Paulus, Carolyn, Phillips, Lawrence, Reddick, William, Reed, John, Rowe, Shasta, Sadler, Barney, Sapp, Tabby, Savoye, Louise, Shore, David, Shuman, Susan, Sittle, Jessica, Standard, Shana, Wardell, Karla, Workman, Amy, Carreira, Tabitha, Fitz-Patrick, David, Hean, Vutheary, Limcolioc, April, Nihei, Megan, Park, Youngmee, Pau, Cindy, Shannon, Lindsey, Trotter, Alanna, Williams, Sierra, Coughenour, Tiffany, Liljenquist, John, Vance, Carl, Williams, Jonathan, Agaiby, Eva, Agaiby, John, Argo, Kelly, Azad, Nasrin, Backus, Arnetta, Bartlett, Andrew, Bellucci-Jackson, Jennifer, Boncu, Otilia, Brodt, Pamela, Carlson, Hope, Collins, Kathleen, Delibasic, Maja, Dor, Isaac, Dukett, Mary, Emanuele, Nicholas, Gabel, Faith, Giardino, Alexandra, Hoelzer, David, Hsieh, Annming, Jayaramaiah, Poornima, Kearney, Tracy, Kelley, Kathleen, Kravarusic, Jelena, Lawless, Andrea, Maheshwari, Hiralal, Martin, Elonia, McCall, Linda, Mikell, Frank, Nallala, Deepika, Said, Sufyan, Sakla, Nadia, Schiferi, Joanna, Smith, Patricia, Stokes, John, Sugimoto, Danny, Sugimoto, Michael, Swan, Delores, Alfata, Sarab, Beavins, Jill, Bogardus, Christine, Bogardus, Donald, Calvert, Brittany, Calvin, Krystle, Carlton, Kristin, Condit, Jonathan, Cornett, George, Covert, Carissa, Dela Llana, Alexander, Dixon, Rosie, Felker, Dean, Fogle, Sara, Harris, Leslie, Hoebeke, Roberta E., Silva, Ricardo, Johnson, Tabitha, Johnston, Kelly, King, Jennifer, Lang, Amber, Maynard, Kenneth, McDaniel, Vickie, McGrath, Caitlin, Moretto, Thomas, Ndukwu, Ikeadi, O'Connor, Leo, O'Connor, Thomas, Oliver, Tonya, Overmars, Stephanie, Patel, Minesh, Patterson, Geraldine, Powell, Talessa, Raphael, Annmarie, Raphael, Rod, Reedy, Mark, Reyes, Hubert S., Ridge, Terry, Rutherford, Mary S., Sebastian, Mike, Shaeffer, Laura, Sheets, Michelle, Thomas, Karen, Trueblood, Nancy, Tucker, Tiffany, White, Adrian, Wooldridge, Evan, Wright, Alison, Zapinski, Dawn, Cieloha, Megan, Coker, Clarine, Fletcher, Cherisa, Kay, Jennifer, Larsen, Katelyn, Marar, Isam, Motz, Zachary, Paul, Jamie, Pokorski, Alan, Rabadi-Marar, Diana, Scheideler, Kylie, Sobczyk, Jill, Sweeney, Kolbie, Brink, Nathalie, Buth, Dennis, Grimes, Katlyn, Lakin, Gregory, Loewen, Barbara, Secrist, Neal, Simon, William, Steere, Diane, Talbot, Kimberly, Wheeler, Christina, Adams, Derick, Armour, Wilhelmina, Asher, Whitney, Bays, Harold, Behl, Noreen, Conn, Brittany, Dye, Lyndsey, Earl, Jennifer, Farris, Neil, Figueroa, Sergio, Fruit, Olivia, Hobbs, Coury, Howard, Kristen, Jackson, Tamara, Kain, Angela, Karounos, Chrisi, Keiran, Sarah, Kennedy, Ryan, King, Kara, Krishnasamy, Sathya, Lambdin, Winona, Micklewright, Gezina, Mokshagundam, Sri, Mooney, Stephen, Moore, Melanie, Morgan, Denise, Morley, Robert, Newsome, Stacy, Nichols, Jennifer, Nims, Diana, Nockerts, Nichole, Oremus, Ruth, Ritchey, Barbara Michelle, Shelton, Christina, Smith, Danielle, Walker, Debra, Weiter, Kathleen, Whitehead, Rebecca, Wood, Robert, Woodruff, Robin, Young, J. DeShay, Alper, Arnold, Berry, Martha, Gauthier, Nadine, Griffin, Catina, Haynes, Elvia, Lawrence, Jereta, McCormack, Teraina (Terry), Midyett, Catherine, Rangaraj, Uma, Smith, William, Stricker, Makenzie, Tandron, Ileana, Vargas, Ramon, Wagner, Michele, Albert, Marie, Baillargeon, Gail, Stephens, John, Aroda, Vanita, Dempsey, Michael, Junker, Herman, Lopez, Meyling, Shepard, Marc, Ciccarelli, Carol, Datu, Joycelyn, Gallagher-Dorval, Karen, Hartigan, Celia, Kowaloff, Edward, Lock, John-Paul, Rosano, Nina, Shaw, Bernadette, Thompson, Michael, Abbo, Camerin, Anton, Salwan, Baker, Lydia, Bhan, Arti, Blackmer, Karla, Boley, Bryon, Hyde, Desirae, Bonema, John, Carlin, Tamara, Curran, Nancy, Dandois, Bethani, Dermyer, Abigail, Dubeck, Janet, Elkins, Jennifer, Ferris, Pamela, Fraser, Neil, Kozma, Julia Gargan, Gasparovich, David, Grodman, Robert, Hampson, Jaison, Hewitt, Mitzie, Hiatt, Judy, Hopkins, Ashley, Howard, Jennifer, Joliat, John, Joliat, Jonathan, Kalt, Steven, Katzman, Steven, Kogelman, Jesse, Kruger, Davida, Kurkowski, April, Lambert, Jodi, Levcovici, Elisabeta, Lockwood, Karen, Lumberg, Michael, McMullen, Lindsay, Meyers, Peter, Minto, Carrie, Nelson, Tina, Neuner, Gregory, Nurmi, Kevin, Perkins, Judy, Plunkett, Cynthia, Ruoff, Gary, Samantray, Julie, Sawah, Ahmed, Secord, Samantha, Seyoum, Berhane, Sherman, Sarah, Simpson, Michael, Sinkoff, Mark, Skoney, Joseph, Small, Jami, Szerlong, Heidi, Tinetti, Timothy, Toomey, Adam, VanDerWerff, Holly, Whitehouse, Fred, Wilkins, Raechelle, Wolf, Stephanie, Yarows, Steven, Eldred, Edward, Hester, Kim, Huling, Randall, Moore, Kerry, Preslar, Kristina, Proge, Nakia, Smith, Lora, Young, Gerri, Bybee, Kevin, Carr, George, Case, Christopher, Forker, Alan, Goeke, Lindsay, Kocher, Darlene, Lin, Oscar, Littlefield, James, Mendoza, Robinson, Moore, Michelle, Oberhaus, Barbara, Reed, Larry, Rutherford, Cheryl, Windsor, Sheryl, Ackerman, Kim, Christensen, Reed, De Souza, Jose, Douglas, Kirsten, Hrncirik, Therese, Lefkowicz, Magen, McDonnell, Lindsey, Severa, Larry, Tjaden, Jeffrey, Ward, Laura, Addison, Shayla, Anderson, Robert, Baker, Claire, Baum, Robert, Belitz, Jenny, Boerner, Shannon, Desouza, Cyrus, Drincic, Andjela, Fitzgibbons, William, Francis, Jessica, Garvin, Maureen, Goldner, Whitney, Goodrich, Melissa, Grubbs, Lisa, Hatcher, Theresa, Hochstein, Renee, Hunter, Christine, Keuchel, Janet, Konigsberg, Sarah, Kuechenmeister, Lisa, Mack, Lynn, McKnight, Thomas, Mensik, Hanna, Mitchell, Jan, Moeller, Jennifer, Montanez, Edward, Montoya, Paul, Nemecek, Tiffany, Neumeister, Amy, Newcomb, Jefferey, Pracht, Shelby, Radke, Kaitlin, Rahman, Jennifer, Renter, Samantha, Reynolds, Jill, Grace Rodriguez, Maria, Satorie, Jessica, Schiermann, Lynnda, Severson, Megan, Shivaswamy, Vijay, Snyder, Janice, Tillson, Renee, Vasey, Andrew, Wahl, Timothy, Weeks, William, Wolf, Thomas, Springer, Brian, Mitchell, Janice, Woodruff, Mark, Alvarez, Isis, Bowers, Rachel, Cala-Anaya, Franklin, Castellanos-Rodriguez, Rudiber, Christopher, Janice, Concepcion, Gelvis, Fernandez, Dareana, Ghanem, Paula, Harmon, Nicolette, Kaiser, Heather, Kaplan, Westbrook, Klugh, Serena, Le, Nicholas, Lehrner, Stephanie, Lopez, Robert, Martin, Olga, Martinez, Tina, Martini, Nicole, Molin, Clifford, Nakhle, Samer, Newsome, Yvonne, Neylon, Ellen, Olsen, Jarvis, Palal, Betsy, Philander, Peter, Rosario, Adriana Ruiz, Sanchez, Mary, Sierra-Garcia, Miguel, Smith, Myesha, Trenche, Samuel, Trippi, Danna, Vernetti, Nicholas, Villegas, Laura, White, Briana, Wilcox, Simmon, Carmolli-Cornette, Lisa, Chuang, Ellie, Hoffman, Sheila, Laliberte, Alison, Marshall, Lisa, Meroski, Pamela, O'Neil, Christine, Shippey, Jeanette, Spector, Linda, Cam, Jenny, Chen, Tina, Damle, Jagadish, Holman, Rebecca, Liu, Jenny, Milazzo, Carmelo, Quach, Brenda, Yang, Bin, Ahmad, Basharat, Aro, Dominic, Azeem, Fouzal, Bonaccorso, Antoinette, Brancato, Lenore, Brautigam, Donald, Charatz, Seth, Chiarot, June, Cunningham, Linda, DiCerbo, Nancy, DiGiovanna, Michael, Dluge-Aungst, Dawn, Dolbeer, Traci, Donovan, Daniel, Duma, Carol, Ellwood, Rebecca, Freedman, Zachary, Gorman, Timothy, Gunther, David, Hogan, Eileen, Hoffman, Lisa, Kapoor, Anoop, Kelly, Michelle, Kitchen, Timothy, Lam, David, Levister, Camilla, Levy, Carol, Lopez, Carlos, Lyons-Patterson, Jane, Makam, Sashi, Mauceri, Diana, McClary, Carole, Murak, Daniel, Nolan, Kelly, Nunez, Carlos, Elliott, Theresa Ohlson, Ostrowski, Phillip, Pallai, Ajish, Porges, Andrew, Rodes, Alfredo, Rosenberg, Richard, Rubel, Lance, Serrano, Lelanie, Shannon, Daniel, Sinha, Rabi, Snyder, Brian, Sy, Claude, Tang, Rocky, Varavenkataraman, Raghupathy, Winterberger, Amy, Allen, Stacy, Anderson, Marshall, Asbill, Mark, Beasley, Amanda, Bennett, Chrisitian, Bergamo, Katherine, Bilbro, Scott, Brannock, Sarah, Brown, Laura, Bryant, Danielle, Buck, Genena, Burdette, Tara, Buse, John, Butler, Laura, Caldwell, Ronald, Cannon, Daniel, Cannon, Kevin, Carter, Casey, Cherry, Amanda, Comer, Zoe, Crittenden, Susan, Cuffee, Juanita, Culmer, Dawn, Daly-Barnes, Kristie, Evensen, Erick, Saavedra, Rubin, Dean, John, Dezube, Milana, Diner, Jaime, Dodis, Regina, Dostou, Jean, Duclos, Michelle, Elmore, Miles, Ferree, Kristin, Foster, Leslie, Fuller, Gail, Garner, Susan, Godwin, Sarah, Goley, April, Gore, Whitney, Green, Brenda, Harris, Elizabeth, Harris, Joy, Harris, Rebecca, Hatharasinghe, Roger, Herring, Charles, Hill, Chernessa, Holmes, Robert, Hutchens, Erin, Jennings, Stuart, Kaake, Ashley, Kaygun, Handan, Kirkman, Marian Sue, Kretzschmar, Heather, Lang, Jaqueline, Largay, Joseph, Lewis, Melissa, Long, Maria Ann, Lucas, Kathryn, McCall, Roshanda, McDaniel, Catrina, McGinnis, Lee Ann, Mogabgab, Edward, Montero, Manuel, Montgomery, Richard, Moran, Joseph, Morgan, Katie, Motley, Taylor, Narendran, Mahendra, Narron, Brooke, Newman, Walter, Nicholson, John, Norris, Stephanie, Norton, Jennifer, Nowell, Erin, O'Brien, Heather, Otero, Heydin, Perkins, Victoria, Quesada, Reyna, Raad, George, Raley, Rosalie, Raman, Sujatha, Rappaport, Jonathan, Ray, Robert, Ray, Shannon, Rice, Lucian, Roberts, Christine, Ross, Kaylee, Scanlon, Erica, Schroder, Derek, Schulte, Michelle, Schultzaberger, Richard, Shoffner, Sylvia, Skrzynski, Michael, Smith, Brian, Smith, Holly, Smith, Jennifer, Smith, Justin, Smith, Kendall, Smith, Leigh, Sparks, Jeffrey, Speece, Jessica, Spivey, Jessica, Stebich, Andrew, Temple, Karen, Tessena, Boryana, Thompson, Casey, Traylor, Henry, Turner, Juliana, Turner, Sh-Rhonda, Van Cleeff, Martin, Vukojicic, Katarina, Wanchick, Leslie, Weinrib, Stephen, Werner, Devorah, Wishon, Candace, Wilson, Jonathan, Wilson, Stephanie, Wright, Heather, Young, Laura, Brown, Jamie, Lillestol, Michael, Allen, Mary Jo, Barker, Bruce, Bedel, Gary, Beuerlein, Shawn, Bhati, Amar, Breslaw, Nicole, Brown, April, Burtch, Brian, Check, Ellen, Chiodi, Shawnie, Colosimo, Linda, Cope, Kathie, Coressel, Denise, Cramer, Bethany, Crowel, Amy, Daboul, Nizar, DeLong, Rebecca, Dirkes, William, Farooki, Zia, Fixler, Don, Friedhof, Linda, Griffen, Julie, Hagan, Anjani, Haney, Kevin, Harris, Kira, Hoffmann, Amanda, Hsieh, Ronald, Ismail-Beigi, Faramarz, Kelso, Kim, Khamousia, Nidaa, Kremer, Gerald, Krol, Adrienne, Kulow, Tanya, Kuttler, Mary, Lee, Andy, Leksan, Jane, McElroy-Marcus, Susan, McNeil, Donald, Mulligan, Guy, Pantalone, Kevin, Perrino, Frank, Peysha, Lori, Pickett, Alicia, Pritchard, James, Provanzana, Kathleen, Rancitelli, Philip, Raupp, Randa, Schnall, Adrian, Siddiqui, Jaweriah, Smith, Cynthia, Sood, Ajay, Sortor, Jennifer, Spinelli, Kristin, Taylor, Diana, Thornton, Aaron, Tiktin, Margaret, Twine, Melissa, Urbank, Ann, Voegele, Francis, Wang, Lawrence, Weiss, Daniel, Werner, Amanda, Williams, Daniel, Wilson, Charles, Aberle, Teresa, Arcon-Rios, Sirlys, Arodak, Bassam, Aziz, Ammara, Bixler, Lacey, Brisko, Carolann, Cannon, Melanie, Choe, James, Connery, Lisa, Elkosseifi, Myriam, George, Aja, Hummer, Kimberly, LaBryer, Lauren, Lane, James, Lim, Jonea, Mirza, Lubna, Mittadodla, Saritha, Priest, Diane, Rao, Veitla, Ricci, Cassie, Salazar, Jennifer, Shaw, Jessica, St John, Jennifer, Talsania, Mitali, Joarder, Farahnaz, Riddle, Matthew, Yuen, Kevin, Ahmed, Intekhab, Austin, Barry, Bagnata, Linda, Bartkowiak, Anthony, Batrus, Jennifer, Baumgarten, Thomas, Belejchak, Paula, Belucher, Christine, Benton, Julia, Berger, Peter, Biscoveanu, Mihaela, Blasick, Abbie, Blyler, Kay, Casey, Linda, Chandler, Bronell, Chapman, Kim, Chou, Brian, Cisar, Jennifer, Clatterbuck, Tabetha, Cook, Richard, Cook II, Richard, Dardi, Inderpreet, DeSalle, Dina, Edevane, Shari, Elliott, Kelsey, Everhart, Brian, Furlong, Kevin J., Geishauser, Jennifer, Goisse, Marcy, Goodman, Yvonne, Gordon, Murray, Gutowski, Catherine, Harris, Ronald, Hu, Ying, Hull, Jenny, Iachini, Kathleen, Iannamorelli, Anthony, Jabbour, Serge, Jackson, Timothy, Jameson, Brian, Janosov, Paula, Jordan, Terry, Kennedy, John, Kurtzer, Gayle, Labuda, Joseph, LaRochelle, Anne, Levinson, Lawrence, Madder, Robert, Marconnet, Kari, Mareda, Patricia, Michael, Donna, Michaels, Debra, Miller, Cathy, Miller, Jeffrey, Minnock, Ann, Mitchell, Michele, Moturi, Hemlata, Moyer, Heather, Nagelberg, Steven, Oliver, Michael, Pepe, Constance, Porter, Patricia, Posey, Dora, Purighalla, Raman, Redmond, Jessica, Reiling, Joseph, Reiling, Susan, Rine, Kathy, Rust, William, Sandutch, Jill, Shaffer, Anette, Shalongo, Annette, Shawley, Sarah, Shonk, Pamela, Singh, Vinay, Slucki, Andrea, Spiller, Kellie, Springer, Nina, Sprouse, Heidi, Sun, Albert, Taylor, Judith, Watine, Robert, Watkinson, Jean, Weaver, Nancy, Wenocur, Howard, Yeoman, Gary, Ackermann, Jeremy, Averill, Nathan, Ballard, Thomas, Byars, William, Carter, Caroline, Castay, Cathleen, Cheek, Shonda, Collins, Jessica, Collins-Jamison, Traci, Cooksey, Erin, Crockford, Nicole, Cutshall, Christopher, Dar, Moahad, Drake, Almond, Dugat, Kameron, Durham, John, Durham, Nancy, Eagerton, Donald, Edmonds, Nataish, Farmer III, Joseph, Fogarty, Charles, Gatlin, June, Geisberg, Harry, Grossman, Margaret, Harrell, Wendy, Harrison, John, Harrison, Kristina, Heincelman, Sarah, Holladay, Lauren, Huberty, Chad, Isakov, Ingrid, Jordan, Norma, Kunkel, Michael, Laserna, Susan, Lawrence, Amanda, Lawrence, Andrew, Livingston, Yolanda, Lloyd, Eric, Lopez, Lina, Manuel, Joyce, Mayfield, Ronald, McDonald, Margaret, Morgan, Caroleann, Munn, Joanie, Murphy, Lauren, Nicol, Brent, Nicol, Philip, Norris, Rebecca, Phillips, Bunny, Reeves, Angela, Roach, Jacqueline, Ross, Irene, Santi, Jeffrey, Saunders, Jacqueline, Shugart, Henry, Singleton, Monnieque, Slee, Erin, Smalley, Kathleen, Smith, Kristy, Sofley, Carl, Solheim, Vesna, Spell, Samantha, Tanenberg, Robert, Whitley, Chester, Widel, Michele, Wilhoit, Gordon, Wood, Ruth, Wright, Jaime, Wulf, Alissa, Zapkowski, Julie, Adams, Kristi, Adams, Roberta, Ananthula, Parvati, Bass, Caitlin, Bates, Chad, Baum, Howard, Bays, Anna, Beck, Teresa, Bilbrey, Brett, Brown, Ashley, Carlton, Anna, Carter, Jenny, Cheri, Laura, Childress, Richard, Cloud, Mark, Cohen, A. Jay, Coulter, Alice, Dotson, Kimberly, Green, Christopher, Helton, Ashley, Houstrup, Jody, Huffman, David, Hurst, Fred, Hurst, James, Jantzi, Curtis, Jerkins, Randy, Jerkins, Terri, Jones, Mandy, Kelley, Shane, Kroulek, Judy, Lawhun, Dennis, Lee, Marcus, Louthan, James, Manning, Rickey, May, Michael, Means, Katherine, Monroe, Jeanabe, Morawski, Emily, Morin, David, Morris, Barbara, Murray, John, Nichols, Robert, Olivi, Stacie, Pennington, Kristina, Poe, Jenny, Pour, Omid Rad, Reeves, Michael, Reeves, Pamela, Root, Connie, Rose, Karen, Rutledge, Lily, Ryan, Eugene, Schwartz, Patricia, Shafer, Jennifer, Singh, Chitra, Smith, Ashley, Snow, Rodney, Stamps, Henry, Staton, Peggy, Stevens, Jeffrey, Stovall, Cathy, Sturgeon, Rodney, Tapp, John, Tapp, Stacy, Warner, Carla, Weiss, Melissa, White, Judith, Wierum, Craig, Williams, Konya, Wright, Tiffanie, Abreu, Marconi, Agarwal, Vandana, Ahmad, Aftab, Ahmad, Asma, Ahmed, Faiz, Ahn, Lily, Alaoui, Rachid, Alarcon, Stephanie, Allison, Dale, Annamalai, Rajasekaran, Arain, Khadija, Arellano, Angelica, Arispe, Barbara, Aronoff, Stephen, Arroyo, Jesus, Bachand, Trista, Bailey, Becky, Bajaj, Chris, Banarer, Salomon, Barnella, Christine, Bartz, Mary, Bates, Jason, Becerra, Karen, Benavides, Melissa, Bhuchar, Subodh, Blevins, Thomas, Bonazzi, Amanda, Brinson, Cynthia, Brown, Timiki, Buckley, Brandee, Bunker, Christy, Burbano, Jose, Busch, Vickey, Bustamante, Rosibel, Calais, Natalee, Camacho, Allison, Camp, Shana, Canada, Nancy, Canchola, Daniel, Cano, Monica, Cardenas, Veronica, Carl, Leighton, Casaubon, Luis, Castaneda, Jessica, Castro, Cindy, Ceniceros, Diego, Chaicha-Brom, Tira, Chaudhuri, Sudipta, Chavez-Velazquez, Alberto, Chen, Jocelyn, Cheyne, Theresa, Chilka, Sapna, Chionh, Kristen, Chunawala, Imran, Cope, Pamela, Cotton, Sonja, Daudjee, Munib, Davidson, Tichina, De Loa, Geraldine, Deniega, Ann, Dillow, Naco, Dominguez, Michael, Dorfman, Steven, Doshi, Ankur, Dunnam, Theresa, Dutta, Papiya, Eiler-Prater, Megann, Eizensmits, Christina, Espinosa, Valerie, Evans, Charles, Frisinger, Cathy, Ganta, Shylesh, Galtney, Kirsten, Gammon, John, Garcia, Analisa Marie, Garcia, Ronald, Glaspie, Tina, Golici, Laura, Gonzalez, Julian, Grant, David, Green, Carrie, Groce, Lindsay, Guevara, Stephanie, Gutierrez, Mary, Hance, Cortney, Harden, Tiffany, Harrison, Lindsay, Herrera, Carlos, Hettler, Evelyn, Holcomb, Michelle, Hoste, Laura, Hudson, Tina, Huerta, Leticia, Jain, Mahendra, Jayaram, Preeth, Johnson, Monique, Johnson, Olivia, Jones, Laurie, Joseph, John, Juarez, Misty, Karimjee, Najmuddin, Kephart, Ashley, Khan, Armgan, Khan, Jalil, Killian, Michael, Kniffen, Wendy, Koops, Maureen, Kwan, Louise, La, John, Laabs, Jessica, Ledesma, Gilbert, Lee, Monica, Leuck, Kathryn, Livingston, Carrie, Llanas, Teresa, Longoria, Andy, Lorta, Jesse, Lothringer, Larry, MacAdams, Maria, MacAdams, Michael, MacGillivray, Brian, Mageno, Melissa, Malek, Megan, Manley, Meghan, Marler, Karen, Martinez, Cristina, Massie, Jodi, Mateos, Glenda, Mathew, Reena, Maya, Claudia, Mazour, Meg, Mbogua, Caroline, McClendon, Robert, McMullen, Deirdre, Meisner, Carl, Menchaca, Ethelina, Meyers, Linda, Miklius, Audrey, Milam, Alissa, Milam, Ronnie, Miller, Tracey, Mize, Lisa, Moczygemba, Roger, Nafegar, Alexandria, Naidu, Jayaram, Nair, Archana, Nguyen, Alison, Nielsen, Douglas, Nisnisan, Josier, Nisnisan, Maria, Oden, Wendy, Orsak, Jessica, Ozer, Kerem, Papacostea, Olivia, Panchal, Ravi, Parikh, Manish, Parthiban, Beneta, Perrin, Brittney, Perkins, Harvonya, Poduri, Madhuri, Pop, Laurentiu, Portales, Nancy, Porter-Tucci, Linda, Postell, Sharon, Pucillo, Ronald, Reddy, Madhavi, Reddy, Rajneesh, Almodovar, Ramon Gilberto Reyes, Richard, Timiki, Richardson, Michele, Riesch, Louie, Rivera-Flores, Samuel, Rizvi, Abid, Rizvi, Samana, Rodas, Kristen, Rodgers, Mark, Roe, Erin, Rogers, Rebecca, Romero, Reina, Rooker-Morris, Leslie, Rosenstock, Julio, Sachson, Richard, Salcedo, Alfredo, Schill, Joseph, Schuh, Kristy, Schuster, Randall, Scribner, Anita, Shah, Arunkumar, Shaw, Stephanie, Shirley, Jefferey, Shook, Mindy, Siddiqui, Muhammad, Sims, Jamie, Singh, Kamalpreet, Skero, Jennifer, Smejdir, Debra, Stacey, Amy, Strzinek, Robert, Tan, Anjanette, Tayabali, Khadija, Tercero, Almundena, Terry, Jessica, Tinney, Irene, Toe, Florence, Toler, Sara, Tripathy, Devjit, Tumyan, Anna, Ulrich, Michelle, Underwood, Krissandra, Valdez, Christina, Valdivieso, April, Vanderheiden, Anna, Vandre, Morgan, Vardeman, Megan, Vargas, Richard, Vilchis, Monica, Warne, Desiree, Wallace, Jeannine, Weindorff, Kathleen, Welch, Heather, Wellmon, Brandy, Werntz, Gary, White, Leta, Williams, Tearani, Wilson, Maria, Wilson, Robyn, Wilson, Ronald, Wood, John, Wright, David, Yeatts, Rhonda, Zahir, Rezwana, Crockett, Becky, Fawson, Ashlee, Graham, Timothy, Mitchell, Zachary, Quinn, Sally, Reddy, Deepika, Rhudy, Jackson, Rosen, Priscilla, Shakespear, Kaylynn, Simmons, Debra, Turner, Ashley, Vanderhoof, Erin, Wahl, Matthew, Zubair, Imran, Algus, Michael, Gilbert, Matthew, Gorson, David, Marney, Annis, Rodriguez, Juan Pablo Perdomo, Roth, Marilynn, Scofield, Sheilah, Thottan, Anna, Bittorf, Margaret, Botros, Emad, Carpenter, Jeanette, Dashiell, Carie, Dimascio-Johnson, Nancy, Fredrickson, Sonja, Gruenther, M., Hall, Lisa, Hartman, Aaron, Hiner, Janette, Kelley, Donna, Kimmel, Melissa, Larrick, Laura, Lawson, Marie, Levy, James, Lewis, Teneshia, Lovell, Charles, Newby, James, Nichols, Michelle, O'Donnell, Philip, Orengo, Sheyla, Pecsok, Thomas, Reiss, Lind, Tarkington, Phillip, Yeatts, Donald, Zieve, Franklin, Ahmed, Imtiaz, Ali, Sajid, Anwar, Sami, Cathcart, Harold, Dawson, Lucia, Floresca, Rolando, Galvan, Ashley, Gardner, Timothy, Halsey, Kami, Hashmi, Farrukh, Hegel, Jackie, Landon, Megan, Moulton, Katlynn, Nand, Cheta, Sakic, Amra, Sevey, Brandie, Wilson, Bruce, Ahl, Scott, Blank, Robert, Coly, Gerard, Hoenig, Jennifer, Jain, Rajeev, Joseph, Elizabeth, Kasprzak, Debra, Kisiel, Lalaine, Maaske, Maurene, Manadhar, Smriti, Patel, Shailendra, Sickler, Whitney, Grp, D.E.V.O.T.E. Study, Acibadem University Dspace, Marso S.P., Mcguire D.K., Zinman B., Poulter N.R., Emerson S.S., Pieber T.R., Pratley R.E., Haahr P.-M., Lange M., Brown-Frandsen K., Moses A., Skibsted S., Kvist K., Buse J.B., and Buscemi S

Subjects
Insulin degludec, Blood Glucose, Male, medicine.medical_treatment, DEVOTE Study Group, Insulin Glargine, Type 2 diabetes, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, diabetes, insulin, 0302 clinical medicine, Randomized controlled trial, law, Cardiovascular Disease, GLUCOSE CONTROL, 11 Medical and Health Sciences, RISK, COMPLICATIONS, OUTCOMES, Incidence, General Medicine, Middle Aged, Insulin, Long-Acting, VARIABILITY, Cardiovascular Diseases, diabetes mellitus, Female, Life Sciences & Biomedicine, Human, medicine.drug, medicine.medical_specialty, 030209 endocrinology & metabolism, Aged, Diabetes Mellitus, Type 2, Double-Blind Method, Humans, Hypoglycemia, Hypoglycemic Agents, Medicine (all), Bedtime, Article, EVENTS, 03 medical and health sciences, HYPOGLYCEMIA, Medicine, General & Internal, Internal medicine, Diabetes mellitus, General & Internal Medicine, medicine, Intensive care medicine, METAANALYSIS, Science & Technology, Hypoglycemic Agent, Insulin glargine, business.industry, Insulin, medicine.disease, business, BASAL INSULIN
Abstract

BACKGROUND Degludec is an ultralong-Acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-To-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-To-Target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-To-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-Adjusted secondary outcome. RESULTS Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P

Published
2017

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