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New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin‐naïve people with type 2 diabetes on oral glucose‐lowering drugs: a randomized controlled trial (EDITION 3)
Author(s) -
Bolli G. B.,
Riddle M. C.,
Bergenstal R. M.,
Ziemen M.,
Sestakauskas K.,
Goyeau H.,
Home P. D.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12438
Subject(s) - insulin glargine , medicine , type 2 diabetes , confidence interval , insulin , diabetes mellitus , body mass index , clinical endpoint , endocrinology , randomized controlled trial , gastroenterology
Aims To compare the efficacy and safety of new insulin glargine 300 U/ml ( Gla‐300 ) with that of glargine 100 U/ml ( Gla‐100 ) in insulin‐naïve people with type 2 diabetes using oral glucose‐lowering drugs. Methods The EDITION 3 study was a multicentre, open‐label, parallel‐group study. Participants were randomized to Gla‐300 or Gla‐100 once daily for 6 months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre‐breakfast plasma glucose concentrations of 4.4–5.6 mmol/l (80–100 mg/dl). The primary endpoint was change in glycated haemoglobin ( HbA1c ) from baseline to month 6. The main secondary endpoint was percentage of participants with ≥1 nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia from week 9 to month 6. Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed. Results Randomized participants (n = 878) had a mean (standard deviation) age of 57.7 (10.1) years, diabetes duration 9.8 (6.4) years, body mass index 33.0 (6.7) kg/m 2 and HbA1c 8.54 (1.06) % [69.8 (11.6) mmol/mol]. HbA1c levels decreased by equivalent amounts with the two treatments; the least squares mean difference in change from baseline was 0.04 [95% confidence interval ( CI ) −0.09 to 0.17] % or 0.4 (−1.0 to 1.9) mmol/mol. Numerically fewer participants reported ≥1 nocturnal confirmed (≤3.9 mmol/l) or severe hypoglycaemia from week 9 to month 6 [relative risk ( RR ) 0.89 (95% CI 0.66 to 1.20)] with Gla‐300 versus Gla‐100 ; a significantly lower risk of hypoglycaemia with this definition was found over the 6‐month treatment period [ RR 0.76 (95% CI 0.59 to 0.99)]. No between‐treatment differences in adverse events were identified. Conclusions Gla‐300 is as effective as Gla‐100 in reducing HbA1c in insulin‐naïve people with type 2 diabetes, with lower hypoglycaemia risk.