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Your search keyword '"Selam, J.‐L."' showing total 41 results
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41 results on '"Selam, J.‐L."'

15. Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial.

Author

Davies, M. J., Russell‐Jones, D., Selam, J.‐L., Bailey, T. S., Kerényi, Z., Luo, J., Bue‐Valleskey, J., Iványi, T., Hartman, M. L., Jacobson, J. G., and Jacober, S. J.

Subjects
INSULIN therapy, TYPE 2 diabetes treatment, GLYCOSYLATED hemoglobin, RANDOMIZED controlled trials, TRIGLYCERIDES, PEOPLE with diabetes
Abstract

Aims To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes. Material and methods The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin ( HbA1c) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI, in a subset of patients. Results Peglispro was non-inferior to glargine in HbA1c reduction [least-squares ( LS) mean difference: −0.29%, 95% confidence interval ( CI) −0.40, −0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p = .005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio ( OR) 2.15 (95% CI 1.60, 2.89); p < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c<7.0% [ OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro-treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU/ L), and aspartate transaminase levels (27 vs 24 IU/ L). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro-treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001). Conclusions Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c, more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions. [ABSTRACT FROM AUTHOR]

Published
2016
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16. Similar HbA1c reduction and hypoglycaemia with variable- vs fixed-time dosing of basal insulin peglispro in type 1 diabetes: IMAGINE 7 study.

Author

Garg, S., Selam, J.‐L., Bhargava, A., Schloot, N., Luo, J., Zhang, Q., Jacobson, J. G., and Hoogwerf, B. J.

Subjects
*HYPOGLYCEMIA, *GLYCOSYLATED hemoglobin, *TYPE 1 diabetes, *GLUCOSE analysis, *GLYCEMIC control, *GENETICS, *PREVENTION, INSULIN therapy effectiveness, DOSE-response relationship of insulin
Abstract

Aims To compare 24-hour fixed-time basal insulin peglispro ( BIL) dosing with 8- to 40-hour variable-time BIL dosing for glycaemic control and safety in patients with type 1 diabetes. Primary outcome was non-inferiority of BIL variable-time dosing compared with fixed-time dosing for glycated haemoglobin ( HbA1c) change after 12-week treatment (margin = 0.4%). Materials and methods This Phase 3, open-label, randomized, cross-over study ( N = 212) was conducted at 20 centres in the United States. During the 12-week lead-in phase, patients received BIL daily at fixed-times. Two 12-week randomized cross-over treatment phases followed, where patients received BIL dosed at either fixed- or variable-times. During the 4-week safety follow-up, patients received conventional insulins. Results During the lead-in period, least-squares mean HbA1c decreased from 7.5% to 6.8%. For BIL, variable-time dosing was non-inferior to fixed-time dosing for HbA1c change [least-squares mean difference = 0.06%, 95% confidence interval (−0.01, 0.13)]. In both regimens, HbA1c increased slightly during the cross-over periods, but remained significantly below baseline. Variable- and fixed-time dosing regimens had similar rates of total hypoglycaemia (10.4 ± 0.62 and 10.5 ± 0.67 events/patient/30 days, P = .947) and nocturnal hypoglycaemia (1.3 ± 0.11 and 1.5 ± 0.13 events/patient/30days, P = .060). Comparable proportions of patients achieved HbA1c < 7.0% with variable- [91 (54.5%)] and fixed-time dosing [101 (60.5%)]. Conclusions Treatment with BIL allows patients to use flexible dosing intervals from 8 to 40 hours. Glycaemic efficacy ( HbA1c), glycaemic variability and hypoglycaemia are similar to fixed-time dosing, suggesting that BIL could potentially provide flexibility in dosing for patients who miss their daily basal insulin. [ABSTRACT FROM AUTHOR]

Published
2016
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