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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

Lookup NU author(s): Emeritus Professor Philip Home

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

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.

Publication metadata

Author(s): Riddle MC, Bolli GB, Home PD, Bergenstal RM, Ziemen M, Muehlen-Bartmer I, Wardecki M, Vinet L, Jeandidier N, Yki-Jarvinen H

Publication type: Article

Publication status: Published

Journal: Diabetes Technology & Therapeutics

Year: 2016

Volume: 18

Issue: 4

Pages: 252-257

Print publication date: 01/04/2016

Online publication date: 03/02/2016

Acceptance date: 01/01/1900

Date deposited: 07/02/2017

ISSN (print): 1520-9156

ISSN (electronic): 1557-8593

Publisher: Mary Ann Liebert, Inc. Publishers

URL: http://dx.doi.org/10.1089/dia.2015.0290

DOI: 10.1089/dia.2015.0290

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