Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea-metformin therapy: A randomized, double-blind study (T-emerge 6)

摘要

Aims: This study compared the efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes inadequately controlled with sulphonylurea±metformin. Methods: In this double-blind, double-dummy, parallel-group trial, 760 subjects (49% male, age 56.4years, diabetes duration 8.8years, body mass index 32.7kg/m2 and haemoglobin A1c [HbA1c] 8.3%) were randomized (1:1:1) to subcutaneous injections of taspoglutide 10 or 20mg once weekly or oral pioglitazone 45mg daily. The primary endpoint was change in HbA1c after 24weeks. Results: Mean (±s.e.) HbA1c reductions with taspoglutide 10 (-1.18±0.08%) and 20mg (-1.36±0.08%) were non-inferior to pioglitazone (-1.30±0.08%) (p=0.21 and 0.37, respectively); mean treatment differences were 0.12 (95% confidence interval: -0.03, -0.26) and -0.06 (-0.20, 0.08) for taspoglutide 10 and 20mg versus pioglitazone. Mean (±s.e.) changes in body weight (kg) were -0.8±0.3, -1.0±0.3 and 3.6±0.3 for taspoglutide 10 and 20mg and pioglitazone, respectively; 8, 11 and 1% of patients achieved ≥5% weight loss. A higher incidence of adverse events (AEs) occurred with taspoglutide, predominantly gastrointestinal disturbances and injection-site reactions, resulting in higher rates of discontinuation versus pioglitazone. No treatment differences in serious AEs were observed. Conclusions: Taspoglutide offered good glycaemic control similar to pioglitazone, while achieving beneficial weight loss rather than weight gain, but was associated with more AEs. Due to the higher than expected discontinuation rates, mainly because of gastrointestinal intolerability, the taspoglutide clinical programme was stopped.