METHODS: In this randomized, double-blind, double-dummy, parallel-group trial, patients were randomized to
taspoglutide 10 mg once weekly (QW), 20 mg QW, 100 mg
sitagliptin once daily (QD), or placebo for 24 weeks, followed by 28-week short-term and 104-week long-term extension periods. The primary endpoint was change in
glycosylated hemoglobin (HbA(1c)) after 24 weeks.
RESULTS: In this study, 666 patients (baseline HbA(1c), 7.96% [SD, 0.87]; fasting plasma
glucose, 9.61 mmol/L [2.56];
body weight, 92.4 kg [19.3]) were randomized to
taspoglutide 10 mg QW (n = 190), 20 mg QW (n = 198), 100 mg sitagliptin QD (n = 185), or placebo (n = 93) for 24 weeks. After 24 weeks, least squares mean (SE) HbA(1c) reductions were greater with
taspoglutide 10 mg (-1.23% [0.06]) and 20 mg (-1.30% [0.06]) versus
sitagliptin (-0.89% [0.06]) or placebo (-0.10% [0.08]). Mean treatment differences with
taspoglutide 10 mg and 20 mg were -0.34 (95% confidence intervals [CI]: -0.49, -0.19) and -0.41 (-0.56, -0.26) versus
sitagliptin; and -1.13 (-1.31, -0.95) and -1.20 (-1.38, -1.02) versus placebo.
Weight loss was greater with
taspoglutide 10 mg (-1.8 kg [0.3]) and 20 mg (-2.6 kg [0.3]) than
sitagliptin (-0.9 kg [0.3]) or placebo (-0.5 kg [0.4]). Effects on HbA(1c) and
weight loss continued through 52 weeks of treatment. No cases of severe
hypoglycemia occurred with any active treatment. Gastrointestinal adverse events, and allergic and
injection-site reactions were higher in the
taspoglutide groups, causing higher discontinuation rates. Anti-
taspoglutide antibodies were confirmed in 46% of patients.
CONCLUSION:
Taspoglutide demonstrated better efficacy on
glycemic control and
weight loss than
sitagliptin, but a high incidence of adverse events led to high discontinuation rates. The safety profile of
taspoglutide in this trial was similar to other trials in the clinical program, and led to the discontinuation of dosing.