Similar glucose control with basal bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification

Objective. This study aimed to demonstrate the non-inferiority of 50-week treatment with stepwise insulin intensification of basal bolus insulin analogues [insulin detemir (IDet) and aspart (IAsp)] versus biphasic insulin aspart 30 (BIAsp30) in insulin-naive type 2 diabetes mellitus (T2DM) patients not controlled by oral glucose-lowering drugs (OGLDs). Research design and methods. In this open-label multicentre, multinational, randomized, parallel-arm treat-to-target trial, 403 insulin-naive patients with T2DM in four African countries were randomized to either an IDet + IAsp (n=200) or BIAspl-2-3 (n=203) treatment group. Stepwise insulin intensification was performed at the end of 14, 26 and 38 weeks, depending on HbA(1c) values. The primary endpoint was change in HbA(1c) after 50 weeks of treatment. Safety variables were hypoglycaemia incidence, occurrence of adverse events and weight gain. Results. Non-inferiority of the IDet + IAsp versus BIAspl-2-3 treatment regimen was demonstrated by their similar HbA(1c) levels at the end of trial (IDet + IAsp: baseline 8.6%, 50 weeks 7.4%; BIAspl-2-3: baseline 8.7%, 50 weeks 7.3%; full analysis set difference: 0.1% [95% CI: 0.1, 0.3]; per protocol: 0.2% [95% CI: 0.1, 0.4]). At week 50, 40.3 and 44.9% of patients achieved HbA(1c) <7.0% with IDet + IAsp and BIAspl-2-3, respectively. The rate of overall hypoglycaemia during the trial was also similar in both groups (IDet + IAsp: 9.4 events/patient-year; BIAspl-2-3: 9.8 events/patient-year). Conclusion. Insulin initiation and intensification using IDet + IAsp was not inferior to BIAspl-2-3 in insulin-naive patients with T2DM not controlled by OGLDs. Both regimens led to similar reductions in HbA(1c) values after 50 weeks of treatment. (C) 2014 Elsevier Masson SAS. All rights reserved.