Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study.

ABSTRACT: To evaluate 0.75?mg of dulaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, compared with once-daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D).In this phase III, randomized, open-label, parallel-group, 26-week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ?20?years, with glycated haemoglobin (HbA1c) levels 7.0-10.0% (53-86?mmol/mol), inclusive, were randomized (1?:?1) to receive dulaglutide or glargine. Participants and investigators were not masked to treatment allocation. The primary measure was change from baseline in HbA1c at 26?weeks, analysed using a mixed-effects model for repeated measures, with a predefined non-inferiority margin of 0.4%.At week 26, least-squares (LS) mean (standard error) reductions in HbA1c were -1.44 (0.05)% [-15.74 (0.55)?mmol/mol] in the dulaglutide group and -0.90 (0.05)% [-9.84 (0.55)?mmol/mol] in the glargine group. The mean between-group treatment difference in HbA1c was -0.54% (95% CI -0.67, -0.41) [-5.90?mmol/mol (95% CI -7.32, -4.48)]; p?

SUBMITTER: Araki E 

PROVIDER: S-EPMC5042081 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature