Data from phase 3 trials of an investigational once-weekly injectable human GLP-1 analog-taspoglutide-show that it compares favorably with currently available agents in terms of glycemic control while offering favorable gastrointestinal (GI) tolerability and equal or superior weight loss. Findings at 24 weeks’ follow-up were reported here; the trials are ongoing.
- Taspoglutide (10 mg titrated to 20 mg weekly) was compared with placebo and sitagliptin (100 mg/day orally) in 666 adults with type 2 diabetes inadequately controlled on metformin (patients had to be on a stable dose of metformin of at least 1,500 mg for at least 12 weeks to be eligible). The reductions in hemoglobin (Hb) A1c, the primary endpoint, were 0.10% with placebo, 1.23% with 10 mg of taspoglutide, 1.30% with 20 mg of taspoglutide, and 0.89% with sitagliptin, reported Richard Bergenstal, MD, from the International Diabetes Center, Minneapolis, Minnesota. A dose-dependent reduction in body weight was observed with taspoglutide: patients assigned to 10 mg lost a mean of 1.8 kg, and those assigned to 20 mg lost a mean of 2.6 kg compared with a 0.9-kg weight reduction in the sitagliptin group.
- Taspoglutide 10 mg or 20 mg twice weekly was compared with insulin glargine once daily in 1,049 adult insulin-naive patients with type 2 diabetes inadequately controlled with metformin plus a sulfonylurea. Taspoglutide demonstrated noninferiority versus insulin glargine in reducing glycated hemoglobin levels (reduction of 0.96% in the combined taspoglutide groups vs 0.84% with insulin glargine), and more patients assigned to taspoglutide achieved an glycated hemoglobin level of 6.5% or less (24% vs 14%, respectively), said Michael Nauck, MD, from Diabeteszentrum Bad Lauterberg im Harz, Germany. Taspoglutide recipients had a mean weight loss of 4.1 kg versus 0.4 kg for insulin glargine recipients.
- The safety and efficacy of taspoglutide was compared with exenatide twice daily in an open-label study of 1,189 patients with type 2 diabetes inadequately controlled with metformin +/– a thiazolidinedione. The primary outcome-the change in glycated hemoglobin -was –1.2% with taspoglutide 10 mg, –1.3% with taspoglutide 20 mg, and –1.0% with exenatide, meeting the criterion for noninferiority, said Julio Rosenstock, MD, clinical professor of medicine, University of Texas Southwestern Medical School, Dallas. More patients in the taspoglutide groups achieved target A1c levels of 7% or less compared with exenatide. Weight loss was similar between the 2 agents.
- In all 3 trials, GI complaints (ie, nausea, vomiting, diarrhea) were the most frequent adverse events and occurred significantly more often with taspoglutide than with the comparator agents.