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To use continuous glucose monitoring (CGM)-based time-in-range (TIR) as a primary efficacy endpoint to compare the second-generation basal insulin (BI) analogues insulin glargine 300 U/ml (Gla-300) and insulin degludec 100 U/ml (IDeg-100) in adults with type 1 diabetes (T1D).InRange was a 12-week, multicentre, randomized, active-controlled, parallel-group, open-label study comparing glucose TIR and variability between Gla-300 and IDeg-100 using blinded 20-day CGM profiles. The inclusion criteria consisted of adults with T1D treated with multiple daily injections, using BI once daily and rapid-acting insulin analogues for at least 1 year, with an HbA1c of 7% or higher and of 10% or less at screening.Overall, 343 participants were randomized: 172 received Gla-300 and 171 IDeg-100. Non-inferiority (10% relative margin) of Gla-300 versus IDeg-100 was shown for the primary endpoint (percentage TIR ≥ 70 to ≤ 180 mg/dl): least squares (LS) mean (95% confidence interval) 52.74% (51.06%, 54.42%) for Gla-300 and 55.09% (53.34%, 56.84%) for IDeg-100; LS mean difference (non-inferiority): 3.16% (0.88%, 5.44%) (non-inferiority P = .0067). Non-inferiority was shown on glucose total coefficient of variation (main secondary endpoint): LS mean 39.91% (39.20%, 40.61%) and 41.22% (40.49%, 41.95%), respectively; LS mean difference (non-inferiority) -5.44% (-6.50%, -4.38%) (non-inferiority P .0001). Superiority of Gla-300 over IDeg-100 was not shown on TIR. Occurrences of self-measured and CGM-derived hypoglycaemia were comparable between treatment groups. Safety profiles were consistent with known profiles, with no unexpected findings.Using clinically relevant CGM metrics, InRange shows that Gla-300 is non-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia and safety profiles.

Background: InRange has previously demonstrated that insulin glargine 300 U/mL (Gla-300) is non-inferior to insulin degludec 100 U/mL (IDeg-100) in terms of time in glucose range 70--180 mg/dL (primary endpoint) and total glucose coefficient of variation (CV) as measured by CGM in people with T1D. Methods: InRange (NCT04075513) was a multicenter, randomized, active-controlled, parallel-group, 12-week open-label trial comparing Gla-300 vs. IDeg-100 in adults with T1D using 20-day CGM profiles (≥10 days evaluable) . Here we present data for within- and between-day CV. Results: Overall, 343 participants were randomized (172 Gla-300, 171 IDeg-100) : mean ± SD age was 42.8 ± 13.3 years and T1D duration was 20.5 ± 12.8 years. Both within-day and between-day glucose CV at Week 12 were similar with Gla-300 and IDeg-100 (Table) . Within-day glucose CV at Week 12 was below the threshold for glycemic stability (36%) in both groups and was also similar in both treatment groups irrespective of glycemic stability at baseline (CV ≤36% or >36%) . The LS mean within-day glucose CV of participants with CV >36% at baseline reached 33.67 (Gla-300) and 35.38 (IDeg-100) at Week 12. Conclusion: Using clinically relevant CGM metrics, InRange shows that Gla-300 and IDeg-100 provide similar within- and between-day glucose variability in people with T1D. Disclosure R. M. Bergenstal: Advisory Panel; Hygieia, Medtronic, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Abbott Diabetes, Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, Onduo LLC, Sanofi, United HealthCare Services, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi. T. Battelino: Advisory Panel; Abbott Diabetes, Indigo Diabetes, Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi, Research Support; Medtronic, Novartis Pharmaceuticals Corporation, Novo Nordisk, Zealand Pharma A/S, Speaker’s Bureau; Abbott Diabetes, Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; DreaMed Diabetes, Ltd. S. Edelman: Consultant; Abbott Diabetes, Lilly Diabetes, Sanofi-Aventis U. S., Xeris Pharmaceuticals, Inc. P. Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker’s Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. T. Danne: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Lilly, Medtronic, Novo Nordisk, Roche Pharmaceuticals, Sanofi, Ypsomed AG, Research Support; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Lilly, Medtronic, Novo Nordisk, Roche Pharmaceuticals, Sanofi, Ypsomed AG, Stock/Shareholder; DreaMed Diabetes, Ltd. E. Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. J. Westerbacka: Employee; Sanofi, Stock/Shareholder; Sanofi. B. Mukherjee: Employee; Sanofi, Stock/Shareholder; Sanofi. P. Picard: n/a. V. Pilorget: None. Funding Sanofi

Introduction: Achieving optimal HbA1c in people with T1D requires good treatment acceptance and self-management. Methods: IDMPS is an international, observational study investigating care practices and clinical profiles of people with diabetes in developing countries. The present analysis of Wave 8 evaluated PROs in people with T1D and their associations with glycemic control using 1) the chronic treatment acceptance questionnaire (ACCEPT) to assess acceptance of long-term medication advantages/disadvantages, and 2) the diabetes self-management questionnaire (DSMQ) to assess health-related behaviors. Results: Of 1103 people with T1D (mean ± SD age 34 ± 12 years, diabetes duration 14 ± 10 years, HbA1c 8.6 ± 2.0 %, 52% were women and 19% had HbA1c Conclusions: Further education for people with T1D could improve self-management and consequently could benefit medication effectiveness. Disclosure J. J. Gagliardino: None. J. C. Chan: Board Member; Asia Diabetes Foundation, Consultant; Bayer AG, Boehringer Ingelheim International GmbH, Celltrion, Merck Sharp & Dohme Corp., Roche Diabetes Care, Viatris Inc., Research Support; Applied Therapeutics, AstraZeneca, Eli Lilly and Company, Hua Medicine, Servier Laboratories, Stock/Shareholder; GemVCare Ltd. P. Aschner: Advisory Panel; Merck & Co., Inc., Sanofi, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. H. M. Ilkova: Advisory Panel; Novo Nordisk. A. Ramachandran: None. J. Mbanya: Advisory Panel; Novo Nordisk, Sanofi, Servier Laboratories. M. V. Shestakova: None. V. Pilorget: None. L. Melas-melt: None. J. Chantelot: Employee; Sanofi, Stock/Shareholder; Sanofi. Funding Sanofi

Introduction: Treatment acceptance and self-management are essential for achieving better HbA1c in people with diabetes. Methods: IDMPS is an international, observational study investigating care practices and clinical profiles of people with diabetes in developing countries. This analysis of Wave 8 evaluated PROs in people with T2D and their associations with glycemic control using 1) the chronic treatment acceptance questionnaire (ACCEPT) to assess acceptance of long-term medication advantages/disadvantages, and 2) the diabetes self-management questionnaire (DSMQ) to assess health-related behaviors. Results: Of 2475 people with T2D (mean ± SD age 58 ± 12 years, 51% women, diabetes duration ± 8 years, BMI 31 ± 6 kg/m2, HbA1c 8.0 ± 1.8 %, 43% on insulin, HbA1c Conclusions: Despite high medication acceptance in developing countries, low self-management calls for further education to improve medication effectiveness. Disclosure P.Aschner: Advisory Panel; Merck & Co., Inc., Sanofi, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. J.C.Chan: Board Member; Asia Diabetes Foundation, Consultant; Bayer AG, Boehringer Ingelheim International GmbH, Celltrion, Merck Sharp & Dohme Corp., Roche Diabetes Care, Viatris Inc., Research Support; Applied Therapeutics, AstraZeneca, Eli Lilly and Company, Hua Medicine, Servier Laboratories, Stock/Shareholder; GemVCare Ltd. J.J.Gagliardino: None. H.M.Ilkova: Advisory Panel; Novo Nordisk. A.Ramachandran: None. J.Mbanya: Advisory Panel; Novo Nordisk, Sanofi, Servier Laboratories. M.V.Shestakova: None. V.Pilorget: None. L.Melas-melt: None. J.Chantelot: Employee; Sanofi, Stock/Shareholder; Sanofi. Funding Sanofi

Patients' satisfaction is a key determinant of treatment adherence and persistence, for optimal management of T2D. ATOS, a 12-month prospective observational study conducted in Asia, Middle East, North Africa, Latin America, and Eastern Europe, showed that initiation of Gla-300 in insulin-naïve people with T2D resulted in improved glycemic control with low rates of hypoglycemia. This analysis evaluated changes in treatment satisfaction and health status among participants. Data was collected using PRO questionnaires - Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change versions (DTSQc) , EuroQoL 5-dimension scale version 3L (EQ-5D-3L) at baseline, Month 3, 6 and 12. Overall, 3931 participants completed the questionnaires. Mean ±SD age was 57.5 ±10.6 years, duration of diabetes was 10.1 ±6.2 years and baseline HbA1c was 9.3 ±1.0 %. Treatment satisfaction improved over time (DTSQs score of 21.7 at baseline to 29.8 and 31.3 at Month 6 and 12, respectively) and perceived frequency of hyperglycemia decreased over 12 months. DTSQc results were aligned with DTSQs. EQ-5D-3L results showed that proportion of people with better health status increased over time (Table) . Results showed that initiating Gla-300 in insulin-naïve people with T2D across multiple geographic regions improved treatment satisfaction and health status. Disclosure N.Khan: None. G.R.Galstyan: n/a. A.Tirosh: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Novo Nordisk, Sanofi, Consultant; Bayer AG, DreaMed Diabetes, Ltd., Research Support; Medtronic, Speaker's Bureau; Eli Lilly and Company. A.Bhansali: None. H.Vargas-uricoechea: Advisory Panel; Sanofi, Speaker's Bureau; Abbott. S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. A.Roborel de climens: Employee; IQVIA Inc., Sanofi. M.N.Mabunay: Employee; Sanofi. M.Coudert: Employee; Sanofi. V.Pilorget: None. Funding Sanofi

The efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbAA total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbAIn people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.NCT03760991.The online version contains supplementary material available at 10.1007/s13300-022-01271-7.

The clinical benefits of insulin glargine 300 U/mL (Gla-300) have been confirmed in randomised clinical trials (EDITION programme and BRIGHT) and real-world studies in the USA and Western Europe. ATOS evaluated the real-world effectiveness and safety of Gla-300 in wider geographic regions (Asia, the Middle East, North Africa, Latin America and Eastern Europe).This prospective observational, international study enrolled adults (≥ 18 years) with type 2 diabetes mellitus (T2DM) uncontrolled [haemoglobin A1c (HbA1c) 7% to ≤ 11%] on one or more oral anti-hyperglycaemic drugs (OADs) who had been advised by their treating physician to add Gla-300 to their existing treatment. The primary endpoint was achievement of a pre-defined individualised HbA1c target at month 6.Of the 4550 participants included, 4422 (51.8% female) were eligible for assessment. The mean ± standard deviation (SD) age was 57.2 ± 10.8 years, duration of diabetes was 10.2 ± 6.2 years and baseline HbA1c was 9.28 ± 1.0%. The proportion of participants reaching their individualised glycaemic target was 25.2% [95% confidence interval (CI) 23.8-26.6%] at month 6 and 44.5% (95% CI 42.9-46.1%) at month 12. At months 6 and 12, reductions were observed in HbA1c (-1.50% and -1.87%) and fasting plasma glucose (-3.42 and -3.94 mmol/L). Hypoglycaemia incidence was low, and body weight change was minimal. Adverse events were reported in 283 (6.4%) participants, with 57 (1.3%) experiencing serious adverse events.In a real-world setting, initiation of Gla-300 in people with T2DM uncontrolled on OADs resulted in improved glycaemic control and low rates of hypoglycaemia with minimal weight change.Clinicaltrials.gov number NCT03703869.

ATOS was a 12-month prospective observational study in 18 countries outside US and Western Europe in insulin-naive adults with T2DM, uncontrolled (HbA1c >7-≤11%) on ≥1 oral antihyperglycemic drug. In this subgroup analysis participants were stratified by BL HbA1c: 50% of participants with BL HbA1c Disclosure N. Khan: None. A. Tirosh: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; Self; DreaMed Diabetes, Ltd. H. Vargas-uricoechea: Advisory Panel; Spouse/Partner; Sanofi. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Coudert: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. G. R. Galstyan: None. Funding Sanofi

ATOS, a prospective, 12-month observational study in 18 countries outside US and Western Europe, showed that initiation of Gla-300 in people with T2DM resulted in improved glycemic control with low rates of hypoglycemia and minimal weight change. Here we present the results from a subgroup analysis in participants with (N=581) or without (N=3841) a history of RI (~70% microalbuminuria, Table). Patients with RI were older (62.2±10.3 vs. 56.4±10.7 years), had a longer duration of T2DM (mean: 12.7±6.9 vs. 9.8±6.0 years) and more comorbidities than patients without RI. Baseline HbA1c was comparable between groups (9.3%). Physician-set individualized HbA1c (%) goals at baseline in the RI vs. non-RI groups were Disclosure A. Tirosh: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; Self; DreaMed Diabetes, Ltd. N. Khan: None. H. Vargas-uricoechea: Advisory Panel; Spouse/Partner; Sanofi. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Coudert: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. G. R. Galstyan: None. Funding Sanofi

ATOS was a 12-month prospective observational study in 18 countries outside US and Western Europe in insulin-naive adults with T2DM, uncontrolled (HbA1c >7-≤11%) on ≥1 oral anti-hyperglycemic drug. This subgroup analysis of ATOS compared the effectiveness and safety of Gla-300 in older (≥70 years [Y]; N=514) and younger ( Disclosure G. R. Galstyan: None. A. Tirosh: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; Self; DreaMed Diabetes, Ltd. H. Vargas-uricoechea: Advisory Panel; Spouse/Partner; Sanofi. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Coudert: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. N. Khan: None. Funding Sanofi

Background: The efficacy and safety of switching to Gla-300 in T2DM uncontrolled on BI has been demonstrated in RCTs and RWE studies in the US and EU. However, similar data in wider geographic regions are limited. ARTEMIS-DM is a multicentre, interventional, single-arm, Phase IV study aimed to evaluate the impact of this switch in 14 countries across Asia, Middle East - Africa and Latin America. Methods: ARTEMIS-DM study enrolled participants with HbA1c between 7.5 and 10%. Primary endpoint was change in HbA1c from baseline to 26 weeks. Results: Of 372 participants (50% male), the mean (SD) age was 60.9 (10.0) years and BMI was 29.57 (5.43) kg/m2. Majority of participants (62.6%) were Conclusion: In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration was associated with improved glycemic control and low incidence of hypoglycemia. Disclosure B. Sethi: None. K. Alrubeaan: None. M. Unubol: None. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. B. Berthou: None. V. Pilorget: Employee; Self; Sanofi. G. Frechtel: None. Funding Sanofi

International audience; Aims: To describe glycaemic control and diabetes management in adults with type 1 diabetes (T1DM), in a real-life global setting.Materials and methods: Study of Adults' GlycEmia (SAGE) was a multinational, multicentre, single visit, non-interventional, cross-sectional study in adult patients with T1DM. Data were collected at a single visit, analysed according to predefined age groups (26-44, 45-64, and ≥65 years), and reported across different regions. The primary endpoint was the proportion of participants achieving HbA1c

ATOS is a prospective, 12-month, observational study assessing real-world effectiveness of the second-generation basal insulin analog Gla-300 in emerging markets. Insulin-naïve adults (≥18 years) with T2DM, HbA1c >7-≤11 % and previously treated with ≥1 oral antihyperglycemic drug were recruited in 18 countries. An interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off July 1, 2019); this included 4527 eligible patients (Eastern Europe: 1748; Egypt: 214; India: 1269; Latin America and Caribbean: 317; Western Asia: 882; Southeast Asia: 46; Taiwan: 51). Mean (SD) age was 57.2 (10.8) years, BMI was 29.4 (5.3) kg/m2, and duration of diabetes was 10.2 (6.2) years; 48.4% were male. Physician-set individualized HbA1c (%) goals at baseline were Disclosure G.R. Galstyan: None. A. Bhansali: None. H. Vargas-Uricoechea: Speaker’s Bureau; Self; Sanofi-Aventis. A. Tirosh: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. G. Sun: None. M. Naqvi: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. M. Coudert: Employee; Self; Roche Pharma, Sanofi-Aventis. D. Cherkasov: None. N. Khan: None. Funding Sanofi (ATOS/NCT03703869)

ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours. Disclosure M. Hassanein: Advisory Panel; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.A. Buyukbese: Consultant; Self; Sanofi. R. Malek: None. V. Pilorget: Employee; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi. B. Berthou: None. I. Shaltout: Advisory Panel; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. Speaker’s Bureau; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly and Company, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Funding Sanofi; World Health Organization (CTRI/2019/02/017636)

Most people with T1D do not achieve HbA1c targets, but this may vary with patient- and disease-related factors. SAGE was a multinational, cross-sectional study using data from medical records and interviews of eligible people with T1D for ≥1 year, aged ≥26 years (N=3858). The relationship between each group of selected factors (sociodemographics, diabetes complications and comorbidities, T1D treatment, structure and process of medical care) and HbA1c target achievement (both general [HbA1c Overall, 24.3% of people achieved HbA1c HbA1c target achievement remains a challenge but SAGE identified factors that appear to be associated with HbA1c target achievement, offering opportunities for intervention. Disclosure J. Seufert: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Sanofi. H. Ikegami: None. S. Brette: Other Relationship; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. F. Lauand: Employee; Self; Sanofi. E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. J.J. Gagliardino: None.

T1D is a chronic disease impacting patients’ lives and psychosocial health; we explored how this may vary by age and region. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of participants (N=3858) aged ≥26 years with T1D for ≥1 year. Results from PROs questionnaires (Hypoglycemia Fear Survey [HFS-II], Problem Areas in Diabetes [PAID], Insulin Treatment Satisfaction Questionnaire [ITSQ], Audit of Diabetes-Dependent Quality of Life [ADDQoL]) were analyzed by region (Asia [A], Eastern Europe [EE], Western Europe [WE], Latin America [LA], Middle East [ME]) and age group (26- HFS-II scores showed fear of hypoglycemia was lowest in A for all age groups (Table). HFS-II scores increased with age in EE and decreased with age in LA. PAID scores showed highest levels of emotional distress in ME for all age groups. ITSQ scores showed treatment satisfaction increased with age in WE, LA and ME, and was more stable in EE and A. ADDQoL total scores showed a small negative impact of T1D on quality of life, with the highest and lowest impact in EE and ME, respectively, across all ages. PROs scores indicated relatively low levels of diabetes-related impact and high treatment satisfaction. Age and regional differences may reflect variations in T1D control and management, as well as cultural and healthcare-system-related factors. Disclosure L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. F. Ampudia Blasco: None. S. Brette: Other Relationship; Self; Sanofi. D. Bruttomesso: Consultant; Self; Abbott, Eli Lilly and Company, Movi, Novo Nordisk, Roche Diagnostics, Sanofi. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck & Co., Inc. H. Ikegami: None. D. Jurišic-Eržen: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. V. Pilorget: Employee; Self; Sanofi. R. Balamurugan: None. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. A. Roborel de Climens: Employee; Self; Sanofi. Funding Sanofi

ORION was a prospective, observational study evaluating the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people with type 2 diabetes (T2DM) who fast during Ramadan. Adults with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks prior to inclusion, and intended to continue its use during Ramadan were enrolled in 11 countries. During Ramadan, Gla-300 treatment was adjusted as per routine practice by the treating physician. Overall, the majority of people (402 [85%]) fasted for the entire Ramadan period and 10.8% fasted for ≥25 days but with at least one missed day. Mean (SD) age was 54.4 (11.0) years, 51.7% were male, BMI was 29.7 (5.3) kg/m2, and duration of diabetes was 10.7 (7.0) years. Risks of diabetes-related complications associated with fasting were assessed by physicians according to IDF-DAR fasting risk category; risk was low/moderate in 82.8%, high in 14.3%, and very high in 2.9% of people. The proportion of people with ≥1 severe and/or documented symptomatic (SMPG ≤70 mg/dL) hypoglycemia event was low (2.2% [event rate: 0.021 per participant-month (PPM)] in pre-Ramadan, 2.6% [0.039 PPM] in Ramadan and 0.2% in post-Ramadan [0.003 PPM]). Overall, 0.8% (0.005 PPM) of participants experienced severe and/or documented symptomatic hypoglycemia at SMPG

Introduction Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need. Methods InRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days. Planned outcomes The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice. Trial registration NCT04075513. Electronic Supplementary Material The online version of this article (10.1007/s13300-020-00781-6) contains supplementary material, which is available to authorized users.

International audience; Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naïve; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil.Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA1c > 7.0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA1c change [non-inferiority margin 0.3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization.Results: Overall, 703 patients were randomized to treatment in REACH (Gla-300, n = 352; SoC, n = 351) and 609 (Gla-300, n = 305, SoC, n = 304) in REGAIN. The primary outcome, non-inferiority of Gla-300 versus SoC for HbA1c change from baseline to month 6, was met in REACH (least squares [LS] mean difference 0.12% [95% CI –0.046 to 0.281]) but not REGAIN (LS mean difference 0.17% [0.015–0.329]); no between-treatment difference in HbA1c change was shown after 12 months in either study. BI dose increased minimally from baseline to 12 months in REACH (Gla-300, +0.17 U/kg; SoC, +0.15 U/kg) and REGAIN (Gla-300, +0.11 U/kg; SoC, +0.07 U/kg). Hypoglycemia incidence was low and similar between treatment arms in both studies.Conclusions: In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.

Aims A number of insulin regimens are used in type 2 diabetes. This analysis aims to better understand the evolution of insulin therapy in different regions of Europe. Methods Data from people starting any insulin were collected in eastern Europe (EEur: Croatia, Russia, Ukraine), northern Europe (NEur: Finland, Germany, UK) and southern Europe (SEur: France, Italy, Portugal, Spain). Retrospective data on starting insulin and prospective follow-up data were extracted from clinical records. Results At 4 years, 1699 (76.0%) of 2236 eligible people had data. EEur participants were mostly female, younger and had shorter diabetes duration on starting insulin, yet had highest baseline HbA1c and more micro-/macrovascular disease. A majority (60%–64%) in all regions started on basal insulin alone, declining to 30%–38% at 4 years, with most switching to basal + mealtime insulin regimen (24%–40%). Higher baseline (28%) and 4-year use (34%) of premix insulin was observed in NEur. Change in HbA1c (SD) ranged from −1.2 (2.1)% (−13 [23] mmol/mol) in NEur to −2.4 (2.0)% (−26 [22] mmol/mol) in EEur. Weight change ranged from +1.9 (8.3) kg in NEur to +3.2 (7.0) kg in SEur. Overall documented hypoglycemia ranged from 0.3 (1.3) to 1.3 (4.4) events/person/6-months (NEur vs. EEur, respectively) and was stable with time. Severe hypoglycemia rates remained low. Conclusion When starting insulin, HbA1c and prevalence of complications were higher in EEur. Regional differences exist in choice of insulin regimens in Europe. However, people starting insulin improved and sustained their glycemic control regardless of regional differences or insulin regimens used.

OBJECTIVE To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODS In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA1c from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight. RESULTS A total of 350 patients were randomized. HbA1c decreased substantially with lixisenatide (−0.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (−5.12 mmol/L) than with placebo (−0.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (−1.47 kg) versus placebo (−0.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo. CONCLUSIONS In nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.

ORION evaluated the safety and effectiveness of Gla-300 in insulin-treated people with T2DM before, during and after Ramadan, in a real-world setting.This prospective, observational study across 11 countries included participants with T2DM treated with Gla-300 in pre-Ramadan, Ramadan and post-Ramadan periods. The primary endpoint was the percentage of participants experiencing ≥1 event of severe and/or symptomatic documented hypoglycaemia with self-monitored plasma glucose (SMPG) ≤70 mg/dL during Ramadan. Secondary endpoints included change in HbAThe mean ± SD number of fasting days was 30.1 ± 3.2. The percentage of participants experiencing ≥1 event of severe and/or symptomatic documented hypoglycaemia (SMPG ≤70 [54] mg/dL) was low in the pre-Ramadan (2.2% [0.8%]), Ramadan (2.6% [0%]) and post-Ramadan (0.2% [0%]) periods. No participants reported severe hypoglycaemia during Ramadan or post-Ramadan; one participant reported severe hypoglycaemia in pre-Ramadan. HbAIn ORION, people with T2DM treated with Gla-300 who fasted during Ramadan had a low risk of severe/symptomatic hypoglycaemia and improved glycaemic control.

Aims To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. Materials and methods A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists. Results Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and

DUNE was a 12-week, prospective, observational study of 3139 adults with T2DM, newly (at enrollment) or recently ( Disclosure L. Berard: Other Relationship; Self; Abbott, Becton, Dickinson and Company, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi, Montmed Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., LifeScan Canada. Consultant; Self; Ascensia Diabetes Care. Other Relationship; Self; Novo Nordisk Inc., Merck & Co., Inc. D. Mauricio: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Eli Lilly and Company, GlaxoSmithKline plc.. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Janssen-Cilag Pty Limited. Speaker's Bureau; Self; Merck Sharp & Dohme Corp.. Board Member; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Merck Sharp & Dohme Corp.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi. Board Member; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Sanofi. K. Khunti: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Sanofi-Aventis, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Sanofi-Aventis, Pfizer Inc.. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; Novo Nordisk A/S. Consultant; Self; Pfizer Inc.. Research Support; Self; Novo Nordisk A/S. D.R. Franco: Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Abbott. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi, Eli Lilly and Company. Speaker's Bureau; Self; Abbott. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. C. Candelas: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Perfetti: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association.

DUNE, a 12-week, prospective, observational study (Feb 2015–Jul 2016) of 3139 people with T2DM, either newly (at enrollment) or recently ( Disclosure D. Mauricio: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; Eli Lilly and Company, GlaxoSmithKline plc.. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Janssen-Cilag Pty Limited. Speaker's Bureau; Self; Merck Sharp & Dohme Corp.. Board Member; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Merck Sharp & Dohme Corp.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Advisory Panel; Self; Sanofi. Board Member; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Sanofi. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association. E. Orsi: None. V. Klimontov: None. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. L. Melas-Melt: Consultant; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Perfetti: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. K. Khunti: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Sanofi-Aventis, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Consultant; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Sanofi-Aventis, Pfizer Inc.. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis, Takeda Development Centre Europe Ltd., Servier. Research Support; Self; Novo Nordisk A/S. Consultant; Self; Pfizer Inc.. Research Support; Self; Novo Nordisk A/S.

Aims To identify factors associated with glucose control, as measured by HbA1c over 4 years, in people with type 2 diabetes starting insulin therapy. Methods CREDIT, an observational cohort study, collected data semi-annually over 4 years, on people with type 2 diabetes starting any insulin, in 311 centres in 12 countries; 2803 people had data on HbA1c during follow-up. Multivariable backward regression analysis selected characteristics associated with glycaemic control from a limited number of candidate variables. Results Before starting insulin therapy, HbA1c was 9.3% (78 mmol/mol) and decreased to 7.6% (60 mmol/mol) after 1 year, and changed little after that. Insulin dose increased from 0.21 U/kg to 0.36 U/kg at 1 year, and then by 0.10 U/kg over the next 3 years. Body weight increased by 2.0 kg in the first year and increased little thereafter. Poorer glycaemic control over the 4 years was mainly determined by the HbA1c before starting therapy, after accounting for the other statistically significant associated variables in multivariable analysis: higher BMI, younger age, longer diabetes duration, more glucose-lowering drugs, using basal insulin alone, higher insulin dose and female sex. At 4 years, a higher current insulin dose was the characteristic most strongly associated with a higher concurrent HbA1c. Conclusions HbA1c at the start of insulin therapy was the characteristic most predictive of later HbA1c, after accounting for other variables associated with HbA1c. This may provide some justification for earlier insulin introduction to improve glucose control to target.

Aim To identify factors associated with documented symptomatic and severe hypoglycaemia over 4 years in people with type 2 diabetes starting insulin therapy. Materials and methods CREDIT, a prospective international observational study, collected data over 4 years on people starting any insulin in 314 centres; 2729 and 2271 people had hypoglycaemia data during the last 6 months of years 1 and 4, respectively. Multivariable logistic regression was used to select the characteristics associated with documented symptomatic hypoglycaemia, and the model was tested against severe hypoglycaemia. Results The proportions of participants reporting ≥1 non‐severe event were 18.5% and 16.6% in years 1 and 4; the corresponding proportions of those achieving a glycated haemoglobin (HbA1c) concentration

AimWe examined the effects of adding glargine to metformin–sitagliptin (MS+G) or sitagliptin to metformin–glargine (MG+S) therapy in type 2 diabetic persons uncontrolled after 24-week MS or MG dual therapy.MethodsSubjects with A1c≥7% on MS or MG treatment were respectively given glargine (0.2U/kg starting dose) or sitagliptin (100mg daily) for 12weeks. The primary endpoint was number of subjects attaining A1c goal defined as

Objectif TEENs est la plus grande etude contemporaine, internationale, transversale, visant a identifier des approches d'optimisation du controle glycemique des jeunes patients DT1 (20 pays, n =5 960). Nous rapportons ici les donnees de la cohorte europeenne ( n=2 943, 111 centres dans 11 pays, France comprise). Patients et methodes Les donnees ont ete recueillies lors des entretiens avec les patients, d'examens des dossiers medicaux et d'enquetes patient/parents. Les patients ont ete stratifies en trois groupes d'âge: enfants (8-12 ans, n =887), adolescents (13-18 ans, n =1 451) et jeunes adultes (19-25 ans, n =605). L'HbA1c a ete mesuree avec l'A1CNow™ (Bayer ; plage de reference 4-6 %) . Valeurs cibles d'HbA1c % pour les patients ≤ 18 ans (ISPAD) et % pour les patients de 19-25 ans (ADA). Les patients âges de ≥ 13 ans ont rempli le questionnaire PAID (Problem Areas In Diabetes) et leurs parents ont rempli la version revisee du PAID (scores de 0 a 100, 100=maximum de severite). Resultats La duree mediane du DT1 etait de 6,5 ans (intervalle interquartile de 3,7 a 9,9). Le taux d'HbA1c (± ecart-type) etait de 8,1 ± 1,6 %, dont 35 % des patients atteignant les valeurs cible d'HbA1c. Ces derniers (surtout les patients âges de 8-18 ans) avaient tendance a recevoir un traitement plus intensif que ceux n'ayant pas atteint les valeurs cibles d'HbA1c (pompe a insuline 34-35 % vs 29-27 % des patients, autosurveillance glycemique 6,2-5,1 vs 5,5-4,4 fois/j). Les parents/tuteurs ont declare un fardeau de soins plus lourd que les adolescents (scores=47,1 ± 20,5 vs 23,6 ± 18,0 respectivement). Conclusion Environ 1/3 des patients DT1 europeens de 8-25 ans atteignent les valeurs cibles d'HbA1c. Ces patients ont tendance a beneficier d'un traitement et d'une surveillance plus intensifs. Ainsi, il est necessaire d'identifier des approches visant a intensifier le traitement, et a ameliorer le controle glycemique chez les plus jeunes et reduire le fardeau du DT1 chez les jeunes patients europeens. Declaration d’interet Les auteurs declarent avoir un interet avec un organisme prive, industriel ou commercial en relation avec le sujet presente. Consultant scientifique Sanofi.

AimsIt is of interest to understand how insulin therapy currently evolves in clinical practice, in the years after starting insulin in people with type 2 diabetes. We aimed to describe this evolution prospectively over 4 years, to assist health care planning.MethodsPeople who had started any insulin were identified from 12 countries on three continents. Baseline, then yearly follow-up, data were extracted from clinical records over 4 years.ResultsOf the 2999 eligible people, 2272 were followed over 4 years. When starting insulin, mean (SD) duration of diabetes was 10.6 (7.8) years, HbA1c 9.5 (2.0)% (80 [22]mmol/mol) and BMI 29.3 (6.3)kg/m2. Initial insulin therapy was basal 52%, premix 23%, mealtime+basal 14%, mealtime 8% and other 3%; at 4 years, 30%, 25%, 33%, 2% and 5%, respectively, with 5% not on insulin. Insulin dose was 20.2U/day at the start and 45.8U/day at year 4. There were 1258 people (55%) on their original regimen at 4 years, and this percentage differed according to baseline insulin regimen. HbA1c change was −2.0 (2.2)% (−22 [24]mmol/mol) and was similar by final insulin regimen. Hypoglycaemia prevalence was

AimsDemonstrate superiority of insulin glargine (±glulisine) strategy versus premixed insulin strategy for percentage of patients reaching HbA1c