Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).

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Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z

Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).

Diabetes Care. 2014 Aug;37(8):2149-58. doi: 10.2337/dc13-2761. Epub 2014 Apr 17.

PubMed ID

24742660 [ View in PubMed

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Abstract

OBJECTIVE: To compare the efficacy and safety of two doses of once-weekly dulaglutide, a glucagon-like peptide 1 receptor agonist, to sitagliptin in uncontrolled, metformin-treated patients with type 2 diabetes. The primary objective was to compare (for noninferiority and then superiority) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c (HbA1c) at 52 weeks. RESEARCH DESIGN AND METHODS: This multicenter, adaptive, double-blind, parallel-arm study randomized patients (N = 1,098; mean baseline age 54 years; HbA1c 8.1% [65 mmol/mol]; weight 86.4 kg; diabetes duration 7 years) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, sitagliptin 100 mg, or placebo (placebo-controlled period up to 26 weeks). The treatment period lasted 104 weeks, with 52-week primary end point data presented. RESULTS: The mean HbA1c changes to 52 weeks were (least squares mean +/- SE): -1.10 +/- 0.06% (-12.0 +/- 0.7 mmol/mol), -0.87 +/- 0.06% (9.5 +/- 0.7 mmol/mol), and -0.39 +/- 0.06% (4.3 +/- 0.7 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg, and sitagliptin, respectively. Both dulaglutide doses were superior to sitagliptin (P < 0.001, both comparisons). No events of severe hypoglycemia were reported. Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg (-3.03 +/- 0.22 kg) and dulaglutide 0.75 mg (-2.60 +/- 0.23 kg) compared with sitagliptin (-1.53 +/- 0.22 kg) (P < 0.001, both comparisons). The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5- and 0.75-mg arms were nausea, diarrhea, and vomiting. CONCLUSIONS: Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.

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Drug Targets

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