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  • Title: Efficacy and safety of taspoglutide in patients with type 2 diabetes inadequately controlled with metformin plus pioglitazone over 24 weeks: T-Emerge 3 trial.
    Author: Henry RR, Mudaliar S, Kanitra L, Woloschak M, Balena R, T-Emerge 3 Study Group.
    Journal: J Clin Endocrinol Metab; 2012 Jul; 97(7):2370-9. PubMed ID: 22539590.
    Abstract:
    OBJECTIVE: This study assessed the efficacy and safety of once-weekly taspoglutide in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone compared with placebo. DESIGN: In this randomized, double-blind, parallel-group, placebo-controlled trial (T-emerge 3), 326 patients were randomized to once-weekly sc injections of taspoglutide 10 mg, taspoglutide 20 mg (10 mg for first 4 wk), or placebo. The primary endpoint was change from baseline in glycosylated hemoglobin (HbA1c) at 24 wk. RESULTS: A significant reduction in HbA1c was observed with taspoglutide 10 mg and 20 mg vs. placebo (least square mean -1.35 and -1.40% vs. -0.45%, respectively; P < 0.0001). A greater proportion of taspoglutide-treated patients reached HbA1c target 7% or less (69.8 and 76.1% vs. 35.1%). With taspoglutide 10 mg and 20 mg vs. placebo, significantly greater reductions in fasting plasma glucose [-1.87 mmol/liter (-34 mg/dl) and -2.12 mmol/liter (-38 mg/dl) vs. -0.57 mmol/liter (-10 mg/dl); P < 0.0001], improvements in homeostasis model assessment of β-cell function score (20.65 and 33.52 vs. -2.03; P < 0.0001), and significant weight loss (-0.64 kg and -1.04 kg vs. 0.59 kg; P < 0.01) were observed. Adverse events were generally mild to moderate; the most frequent adverse events with taspoglutide 10 mg, taspoglutide 20 mg, and placebo were nausea (35, 44, and 10%), vomiting (21, 24, and 2%), and injection site reactions (24, 24, and 5%). CONCLUSIONS: Taspoglutide provided glycemic control with weight loss as add-on therapy to metformin plus pioglitazone for inadequately controlled type 2 diabetes mellitus.
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