4 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

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