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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Riddle , M C , Bolli , G B , Home , P D , Bergenstal , R M , Ziemen , M , Muehlen-Bartmer , I , Wardecki , M , Vinet , L , Jeandidier , N & Yki-Jarvinen , H 2016 , ' Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300 U/mL in People with Type 2 Diabetes ' , Diabetes Technology & Therapeutics , vol. 18 , no. 4 , pp. 252-257 . https://doi.org/10.1089/dia.2015.0290

Title: Efficacy and Safety of Flexible Versus Fixed Dosing Intervals of Insulin Glargine 300 U/mL in People with Type 2 Diabetes
Author: Riddle, Matthew C.; Bolli, Geremia B.; Home, Philip D.; Bergenstal, Richard M.; Ziemen, Monika; Muehlen-Bartmer, Isabel; Wardecki, Marek; Vinet, Laetitia; Jeandidier, Nathalie; Yki-Jarvinen, Hannele
Contributor: University of Helsinki, Department of Medicine
Date: 2016-04-01
Language: eng
Number of pages: 6
Belongs to series: Diabetes Technology & Therapeutics
ISSN: 1520-9156
URI: http://hdl.handle.net/10138/161394
Abstract: Background: 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. Materials and Methods: 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 (HbA(1c)) 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 HbA(1c) level and other efficacy and safety measures were assessed. Results: 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 HbA(1c) 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. Conclusions: 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.
Subject: GLUCOSE CONTROL
100 UNITS/ML
HYPOGLYCEMIA
ADHERENCE
TRIAL
BASAL
DEGLUDEC
THERAPY
3121 Internal medicine
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