Dataset Information

Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300?U/mL in People with Type 2 Diabetes.

ABSTRACT: Insulin glargine 300?U/mL (Gla-300) has a more constant and prolonged action profile than insulin glargine 100?U/mL and in clinical studies is associated with similar glycemic control but less hypoglycemia. Whether its effects are altered by variability of injection time was examined in two 3-month substudies.Eligible participants completing 6 months of optimized treatment with Gla-300 in EDITION 1 (n?=?109) and EDITION 2 (n?=?89), having a mean hemoglobin A1c (HbA1c) level of 7.3 % (SD 1.0 %), were randomized (1:1) to groups advised to increase variability of between-injection intervals to 24?±?up to 3?h or to maintain fixed 24-h intervals for 3 months. Changes of HbA1c level and other efficacy and safety measures were assessed.In the fixed-dosing group, 64% of participants reported all intervals within the 23-25-h range, compared with 15% of those advised flexible dosing. In the fixed- and flexible-dosing groups, 12% and 41%, respectively, of between-injection intervals were outside the 23-25-h range, and 2% and 16%, respectively, were outside the 21-27-h range. Least squares mean between-group difference in HbA1c change from baseline was 0.05 % (95% confidence interval [CI], -0.13 to 0.23); for fasting plasma glucose, 2.7?mg/dL (95% CI, -9.0 to 14.4); and for daily basal insulin dose, 0.00?U/kg (95% CI, -0.02 to 0.03). Frequencies of hypoglycemia and adverse events did not differ between groups.The efficacy and safety of Gla-300 demonstrated in EDITION 1 and EDITION 2 are maintained in substudies when the insulin was injected up to 3?h before or after the usual time of administration.

SUBMITTER: Riddle MC

PROVIDER: S-EPMC4827283 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300 U/mL in People with Type 2 Diabetes.

Riddle Matthew C MC Bolli Geremia B GB Home Philip D PD Bergenstal Richard M RM Ziemen Monika M Muehlen-Bartmer Isabel I Wardecki Marek M Vinet Laetitia L Jeandidier Nathalie N Yki-Järvinen Hannele H

Diabetes technology & therapeutics 20160203 4

<h4>Background</h4>Insulin glargine 300 U/mL (Gla-300) has a more constant and prolonged action profile than insulin glargine 100 U/mL and in clinical studies is associated with similar glycemic control but less hypoglycemia. Whether its effects are altered by variability of injection time was examined in two 3-month substudies.<h4>Materials and methods</h4>Eligible participants completing 6 months of optimized treatment with Gla-300 in EDITION 1 (n = 109) and EDITION 2 (n = 89), having a mean h ...[more]

PMID: 26840338

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Project description:INTRODUCTION:This study aimed to determine, in close to real-life conditions, the efficacy and safety of switching from any basal insulin to insulin glargine 300 U/mL (Gla-300) in patients with uncontrolled type 2 diabetes (T2D). METHODS:This was an interventional, multicenter, single-arm, prospective study with a 24-week treatment phase. Adult patients with T2D treated with basal insulin with or without other antidiabetics, HbA1c > 7.5%, and fasting self-monitored blood glucose (F-SMBG) > 130 mg/dL (mean of three measures) at baseline were included. Insulin dose was titrated to reach F-SMBG 90-130 mg/dL. Efficacy and safety were assessed at 12 weeks (W12) and 24 weeks (W24). The main outcome parameter was HbA1c change between baseline and W24. Safety parameters included self-reported hypoglycemia (any type). Patients' satisfaction with the treatment was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). RESULTS:A total of 140 patients were included and 137 were treated. Mean HbA1c decreased from 8.64% at baseline to 8.14% at W12 (mean difference [95% CI] - 0.51% [- 0.64; - 0.38]) and 8.01% at W24 (- 0.64% [- 0.81; - 0.46]). Target F-SMBG was reached in 35.0% of the patients at W12 and 38.4% at W24. The percentages of patients reaching HbA1c levels < 7.0%, < 7.5%, and < 8.0% at W24 were 11.4%, 29.5%, and 50.8%, respectively, while only 31.6% had an HbA1c value < 8.0% at baseline. HbA1c reduction was greater in patients with higher baseline levels. During the treatment phase, 46.0% of the participants had at least one hypoglycemia event; 31.4% documented symptomatic hypoglycemia, 2.2% severe hypoglycemia, and 12.2% nocturnal hypoglycemia. Treatment satisfaction increased by 20% between baseline and W24. CONCLUSION:These data, derived from close to real-life practice in France, confirm the reassuring results of randomized trials on the efficacy and safety of Gla-300. TRIAL REGISTRATION:EudraCT number 2015-002416-33.

Dataset Information

Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300?U/mL in People with Type 2 Diabetes.

Publications

Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300 U/mL in People with Type 2 Diabetes.

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