Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naive people with type 2 diabetes: The EDITION AP randomized controlled trial.

ABSTRACT:

Aim

To compare the efficacy and safety of Gla-300 versus Gla-100 in insulin-naïve people with type 2 diabetes in Asia Pacific.

Materials and methods

In this open-label, randomized, active-controlled, 26-week study, insulin-naïve participants with type 2 diabetes inadequately controlled with non-insulin antihyperglycaemic drugs were randomized (2:1) to Gla-300 or Gla-100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8-12 weeks to a target fasting self-monitored plasma glucose (SMPG) of 4.4-5.6 mmol/L.

Results

Of the 604 participants randomized, 570 (Gla-300, n = 375; Gla-100, n = 195) completed the study. Non-inferiority of Gla-300 versus Gla-100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla-300 and G

SUBMITTER: Ji L 

PROVIDER: S-EPMC7384042 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature