We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension.
- Authors
Riddle, M. C.; Yki‐Järvinen, H.; Bolli, G. B.; Ziemen, M.; Muehlen‐Bartmer, I.; Cissokho, S.; Home, P. D.
- Abstract
Aims To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml ( Gla-300) versus glargine 100 U/ml ( Gla-100) in people with type 2 diabetes mellitus ( T2DM) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. Methods EDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100, as previously randomized, once daily for a further 6-month open-label extension phase. Changes in glycated haemoglobin ( HbA1c) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. Results Of 807 participants enrolled in the initial phase, 89% (359/404) assigned to Gla-300 and 88% (355/403) assigned to Gla-100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c: Gla-300, 7.24%; Gla-100, 7.42%), with more sustained HbA1c reduction for Gla-300 at 12 months: least squares mean difference Gla-300 vs Gla-100: HbA1c −0.17 [95% confidence interval ( CI) −0.30 to −0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla-300 and 0.90 U/kg for Gla-100. Lower percentages of participants had ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event with Gla-300 than Gla-100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89-0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75-0.94)], while the annualized rates of such hypoglycaemic events were similar. No between-treatment differences in adverse events were apparent. Conclusion During 12 months of treatment of T2DM requiring basal and meal-time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla-300 than with Gla-100. The mean basal insulin dose was higher with Gla-300 compared with Gla-100, but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments.
- Subjects
HYPOGLYCEMIA; INSULIN; GLYCOSYLATED hemoglobin; BLOOD sugar; GLUCOSE; RANDOMIZED controlled trials
- Publication
Diabetes, Obesity & Metabolism, 2015, Vol 17, Issue 9, p835
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12472