Take Control: A Randomized Trial Evaluating the Efficacy and Safety of Self- Versus Physician-Managed Titration of Insulin Glargine 300 U/mL (Gla-300) in Patients with Uncontrolled Type 2 Diabetes

Aim To compare the efficacy and safety of self‐ vs physician‐managed titration of insulin glargine 300 U/mL (Gla‐300), in patients with inadequately controlled type 2 diabetes. Methods Take Control (EudraCT number: 2015‐001626‐42) was a 24‐week, multinational, open‐label, controlled, 2‐arm, parallel‐group study in insulin‐naïve and pre‐treated patients, randomized 1:1 to a self‐ or physician‐managed titration of Gla‐300. The fasting self‐monitored plasma glucose (SMPG) target was 4.4–7.2 mmol/L. The primary outcome was non‐inferiority of HbA1c change from baseline to week 24. Secondary outcomes included SMPG target achievement without hypoglycaemia, hypoglycaemia incidence, adverse events and patient‐reported outcomes (PROs). Results At week 24, the least squares (LS) mean HbA1c reduction was 0.97 % and 0.84 % in the self‐ and physician‐managed groups, respectively, with an LS mean difference of −0.13 % [95% CI: −0.2619 to −0.0004] demonstrating non‐inferiority (p