3 years ago

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL: one-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes

Ronan Roussel, Hannele Yki-Järvinen, Jiten Vora, Robert Ritzel, Andrea Giaccari, Claire Brulle-Wohlhueter
Aims To investigate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) over 12 months in a patient-level meta-analysis using data from EDITION studies in people with type 2 diabetes (T2DM). Methods EDITION 1, 2 and 3 were multicentre, randomised, open-label, two-arm, parallel-group, treat-to-target phase 3a studies. Similar study designs and endpoints enabled a meta-analysis to be conducted. Results Reductions in HbA1c were better sustained over 12 months with Gla-300 than Gla-100 (least squares [LS] mean difference in change from baseline: −0.10 [95% confidence interval (CI): −0.18 to −0.02] % [−1.09 (−2.01 to −0.20) mmol/mol] [p = 0.0174]). Risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla-300 versus Gla-100 at night (relative risk 0.85 [95% CI: 0.77 to 0.92]) and 6% lower at any time of day (0.94 [0.90 to 0.98]). Rates of hypoglycaemia were 18% lower with Gla-300 versus Gla-100 at night (rate ratio 0.82 [0.67 to 0.99]), but comparable at any time of day. HbA1c <7.0 % without nocturnal hypoglycaemia was achieved by 24% more participants with Gla-300 versus Gla-100 (relative risk 1.24 [1.03 to 1.50]). Severe hypoglycaemia was rare; in both treatment groups incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant-year. Conclusions In a broad population of people with T2DM over 12 months, use of Gla-300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day, versus Gla-100.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/dom.13105

You might also like
Never Miss Important Research

Researcher is an app designed by academics, for academics. Create a personalised feed in two minutes.
Choose from over 15,000 academics journals covering ten research areas then let Researcher deliver you papers tailored to your interests each day.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.