Take Control: A randomized trial evaluating the efficacy and safety of self- versus physician-managed titration of insulin glargine 300?U/mL in patients with uncontrolled type 2 diabetes.

ABSTRACT: AIM:To compare the efficacy and safety of self- versus physician-managed titration of insulin glargine 300?U/mL (Gla-300) in people with inadequately controlled type 2 diabetes. METHODS:Take Control (EudraCT number: 2015-001626-42) was a 24-week, multi-national, open-label, controlled, two-arm, parallel-group study in insulin-naïve and pre-treated participants, randomized 1:1 to a self- or physician-managed titration of Gla-300. The fasting self-monitored plasma glucose (SMPG) target was 4.4 to 7.2 mmol/L. The primary outcome was non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and participant-reported outcomes (PROs). RESULTS:At week 24, the least squares (LS) mean HbA1c reduction was 0.97% (10.6 mmol/mol) and 0.84% (9.2 mmol/mol) in the self- and physician-managed groups, respectively, with an LS mean difference of -0.13% [95% confidence interval -0.2619 to -0.0004] (-1.4 mmol/mol [-2.863 to -0.004]), demonstrating non-inferiority (P?

SUBMITTER: Russell-Jones D 

PROVIDER: S-EPMC6767413 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature