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Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials.

ABSTRACT: Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM) and new generation basal insulins may improve patient outcomes. This post-hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomised, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1, and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomised to Gla-300 and Gla-100, HbA1c reductions were similar. Fewer participants experienced ?1 SH event with Gla-300 (6.2%) than Gla-100 (9.3%). From baseline to Month 6, the risk of a first SH event was lower with Gla-300: hazard ratio, 0.65 (95% confidence interval [CI] 0.44-0.98; stratified log-rank test, P = 0.038). SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]). Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period. This article is protected by copyright. All rights reserved.

SUBMITTER: Danne T

PROVIDER: S-EPMC7540568 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.

Danne Thomas T Matsuhisa Munehide M Sussebach Christian C Goyeau Harmonie H Lauand Felipe F Niemoeller Elisabeth E Bolli Geremia B GB

Diabetes, obesity & metabolism 20200721 10

Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM), and new-generation basal insulins may improve patient outcomes. This post hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomized, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1 and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Am ...[more]

PMID: 32515543

Dataset Information

Lower Risk for Severe Hypoglycaemia with Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Participants with Type 1 Diabetes: a Meta-Analysis of 6-Month Phase 3 Clinical Trials.

Publications

Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.

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