Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).

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Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V

Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).

Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.

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26089386 [ View in PubMed

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Abstract

OBJECTIVE: This study compared the efficacy and safety of once-weekly dulaglutide, a glucagon-like peptide-1 receptor agonist, with daily insulin glargine, both combined with maximally tolerated doses of metformin and glimepiride in patients with type 2 diabetes. The primary objective was noninferiority of dulaglutide 1.5 mg to glargine in the HbA1c change from baseline at 52 weeks. RESEARCH DESIGN AND METHODS: In this 78-week, open-label study, 810 patients were randomized to dulaglutide 1.5 mg, dulaglutide 0.75 mg, or glargine. RESULTS: The baseline mean +/- SD HbA1c was 8.1 +/- 1.0% (65.5 +/- 10.8 mmol/mol). The least squares mean +/- SE HbA1c change from baseline to the primary end point was -1.08 +/- 0.06% (-11.8 +/- 0.7 mmol/mol) for dulaglutide 1.5 mg, -0.76 +/- 0.06% (-8.3 +/- 0.7 mmol/mol) for dulaglutide 0.75 mg, and -0.63 +/- 0.06% (-6.9 +/- 0.7 mmol/mol) for glargine, with an end point mean +/- SD dose of 29 +/- 26 units (0.33 +/- 0.24 units/kg), and a fasting plasma glucose (mean +/- SD) of 118 +/- 23 mg/dL from self-monitored plasma glucose. Statistical criteria for superiority were met with dulaglutide 1.5 mg and for noninferiority with dulaglutide 0.75 mg. More patients on dulaglutide 1.5 mg achieved HbA1c targets <7.0% (53 mmol/mol) versus glargine (P < 0.001). Body weight decreased with dulaglutide and increased with glargine. Total hypoglycemia rates were lower with dulaglutide; severe hypoglycemia was minimal. Increases in pancreatic enzymes were observed for dulaglutide. Incidence of nausea (15.4, 7.7, and 1.5%) and diarrhea (10.6, 9.2, and 5.7%) were more common with dulaglutide 1.5 mg and 0.75 mg than with glargine. CONCLUSIONS: Once-weekly dulaglutide 1.5 mg, compared with daily insulin glargine without forced titration, demonstrated greater HbA1c reduction and weight loss, with a higher incidence of gastrointestinal adverse events and a lower risk of hypoglycemia.

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Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Dulaglutide	Glucagon-like peptide 1 receptor	Protein	Humans	Yes	Agonist	Details