Efficacy and Safety of Taspoglutide Monotherapy in Drug-Naive Type 2 Diabetic Patients After 24 Weeks of Treatment: Results of a randomized, double-blind, placebo-controlled phase 3 study (T-emerge 1)

OBJECTIVE: To evaluate the efficacy and safety of taspoglutide monotherapy in drug-naive patients with type 2 diabetes inadequately controlled. RESEARCH DESIGN AND METHODS: In this 24-week double-blind, placebo-controlled, multicenter trial, 373 patients with type 2 diabetes naive to antihyperglycemic medication were randomized to weekly subcutaneous taspoglutide 10 or 20 mg or placebo. RESULTS: HbA(1c) reductions from baseline were greater with taspoglutide 10 and 20 mg than placebo (least squares mean [SE] changes: –1.01% [0.07], –1.18% [0.06], and –0.09% [0.07], respectively; both P < 0.0001 vs. placebo). Decreases in bodyweight were greater with taspoglutide 10 mg (–1.45 kg [0.32]) and with 20 mg (–2.25 kg [0.30]) than placebo (–1.23 kg [0.31]; P = 0.61 and P = 0.02 for taspoglutide 10 and 20 mg vs. placebo, respectively). Gastrointestinal adverse events and injection site reactions were more common with taspoglutide than placebo. CONCLUSIONS: In drug-naive patients, once-weekly taspoglutide improved glycemic control, reduced body weight, and was generally well tolerated.