期刊
DIABETES CARE
卷 37, 期 8, 页码 2159-2167出版社
AMER DIABETES ASSOC
DOI: 10.2337/dc13-2760
关键词
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资金
- Eli Lilly and Company
- AstraZeneca
- Bristol-Myers Squibb
- Boehringer Ingelheim
- Intarcia
- Jaeb Center for Health Research
- Janssen
- Merck
- Novo Nordisk
- Sanofi U.S.
- Amylin Pharmaceuticals, Inc.
- GlaxoSmithKline
- Novartis Pharmaceuticals
- Reata Pharmaceuticals
- Sanofi
- Quintiles
- ICON
- Amgen Inc.
OBJECTIVE To compare the efficacy and safety of dulaglutide, a once-weekly GLP-1 receptor agonist, with placebo and exenatide in type 2 diabetic patients. The primary objective was to determine superiority of dulaglutide 1.5 mg versus placebo in HbA(1c) change at 26 weeks. RESEARCH DESIGN AND METHODS This 52-week, multicenter, parallel-arm study (primary end point: 26 weeks) randomized patients (2: 2: 2: 1) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, exenatide 10 mg, or placebo (placebo-controlled period: 26 weeks). Patients were treated with metformin (1,500-3,000 mg) and pioglitazone (30-45 mg). Mean baseline HbA(1c) was 8.1% (65 mmol/mol). RESULTS Least squares mean 6 SE HbA(1c) change from baseline to the primary end point was -1.51 +/- 0.06% (-16.5 +/- 0.7 mmol/mol) for dulaglutide 1.5 mg, -1.30 +/- 0.06% (-14.2 +/- 0.7 mmol/mol) for dulaglutide 0.75 mg, -0.99 +/- 0.06% (-10.8 +/- 0.7 mmol/mol) for exenatide, and -0.46 +/- 0.08% (-5.0 +/- 0.9 mmol/mol) for placebo. Both dulaglutide doses were superior to placebo at 26 weeks (both adjusted one-sided P < 0.001) and exenatide at 26 and 52 weeks (both adjusted one-sided P < 0.001). Greater percentages of patients reached HbA(1c) targets with dulaglutide 1.5 mg and 0.75 mg than with placebo and exenatide (all P < 0.001). At 26 and 52 weeks, total hypoglycemia incidence was lower in patients receiving dulaglutide 1.5 mg than in those receiving exenatide; no dulaglutide-treated patients reported severe hypoglycemia. The most common gastrointestinal adverse events for dulaglutide were nausea, vomiting, and diarrhea. Events were mostly mild to moderate and transient. CONCLUSIONS Both once-weekly dulaglutide doses demonstrated superior glycemic control versus placebo and exenatide with an acceptable tolerability and safety profile.
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