Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)

May 21, 2014Diabetes care

Effectiveness and safety of dulaglutide alone compared to metformin in type 2 diabetes

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Abstract

At 26 weeks, dulaglutide 1.5 mg reduced glycosylated hemoglobin A1c (HbA1c) by -0.78% compared to a reduction of -0.56% with metformin.

Dulaglutide 1.5 mg and 0.75 mg showed greater reductions in HbA1c compared to metformin.
The least squares mean differences in HbA1c between dulaglutide and metformin were -0.22% and -0.15%, respectively.
A higher percentage of patients achieved HbA1c targets of <7.0% and ≤6.5% with dulaglutide compared to metformin.
No severe hypoglycemia was reported with dulaglutide treatment.
Weight decrease was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg when compared to metformin.
Nausea, diarrhea, and vomiting were the most common adverse events, with similar incidences between dulaglutide and metformin.

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OBJECTIVE: Compare the efficacy and safety of monotherapy with dulaglutide, a once-weekly GLP-1 receptor agonist, to metformin-treated patients with type 2 diabetes. The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c (HbA1c) at 26 weeks.

RESEARCH DESIGN AND METHODS: This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg, dulaglutide 0.75 mg, or metformin. Patients (N = 807) had HbA1c ≥6.5% (≥48 mmol/mol) and ≤9.5% (≤80 mmol/mol) with diet and exercise alone or low-dose oral antihyperglycemic medication (OAM) monotherapy; OAMs were discontinued at beginning of lead-in period.

RESULTS: At 26 weeks, changes from baseline HbA1c (least squares [LS] mean ± SE) were: dulaglutide 1.5 mg, -0.78 ± 0.06% (-8.5 ± 0.70 mmol/mol); dulaglutide 0.75 mg, -0.71 ± 0.06% (-7.8 ± 0.70 mmol/mol); and metformin, -0.56 ± 0.06% (-6.1 ± 0.70 mmol/mol). Dulaglutide 1.5 and 0.75 mg were superior to metformin (LS mean difference): -0.22% (-2.4 mmol/mol) and -0.15% (-1.6 mmol/mol) (one-sided P < 0.025, both comparisons), respectively. Greater percentages reached HbA1c targets <7.0% (<53 mmol/mol) and ≤6.5% (≤48 mmol/mol) with dulaglutide 1.5 and 0.75 mg compared with metformin (P < 0.05, all comparisons). No severe hypoglycemia was reported. Compared with metformin, decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg. Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin.

CONCLUSIONS: Dulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes.

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Efficacy and Safety of Dulaglutide Monotherapy Versus Metformin in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-3)

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