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).

Abstract

To evaluate the efficacy and safety of taspoglutide monotherapy in drug-naive patients with type 2 diabetes inadequately controlled. 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. 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. In drug-naive patients, once-weekly taspoglutide improved glycemic control, reduced body weight, and was generally well tolerated.