We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial ( EDITION JP 1).
- Authors
Matsuhisa, M.; Koyama, M.; Cheng, X.; Takahashi, Y.; Riddle, M. C.; Bolli, G. B.; Hirose, T.
- Abstract
Aim To compare efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of insulin glargine 100 U/ml (Gla-100) in Japanese adults with type 1 diabetes. Methods The EDITION JP 1 study ( NCT01689129) was a 6-month, multicentre, open-label, phase III study. Participants (n = 243) were randomized to Gla-300 or Gla-100 while continuing mealtime insulin. Basal insulin was titrated with the aim of achieving a fasting self-monitored plasma glucose target of 4.4-7.2 mmol/l. The primary endpoint was change in glycated haemoglobin ( HbA1c) over 6 months. Safety measures included hypoglycaemia and change in body weight. Results Gla-300 was non-inferior to Gla-100 for the primary endpoint of HbA1c change over the 6-month period {least squares [ LS] mean difference 0.13 % [95 % confidence interval ( CI) −0.03 to 0.29]}. The annualized rate of confirmed (≤3.9 mmol/l) or severe hypoglycaemic events was 34 % lower with Gla-300 than with Gla-100 at night [rate ratio 0.66 (95 % CI 0.48-0.92)] and 20 % lower at any time of day [24 h; rate ratio 0.80 (95 % CI 0.65-0.98)]; this difference was most pronounced during the first 8 weeks of treatment. Severe hypoglycaemia was infrequent. The basal insulin dose increased in both groups (month 6 dose: Gla-300 0.35 U/kg/day, Gla-100 0.29 U/kg/day). A between-treatment difference in body weight change over 6 months favouring Gla-300 was observed [ LS mean difference −0.6 kg (95 % CI −1.1 to −0.0); p = 0.035]. Adverse event rates were comparable between the groups. Conclusions In Japanese adults with type 1 diabetes using basal plus mealtime insulin, less hypoglycaemia was observed with Gla-300 than with Gla-100, particularly during the night, while glycaemic control did not differ.
- Subjects
INSULIN therapy; TREATMENT of diabetes; HYPOGLYCEMIA; BODY weight; GLYCOSYLATED hemoglobin
- Publication
Diabetes, Obesity & Metabolism, 2016, Vol 18, Issue 4, p375
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12619