• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials

• Endocrinology
• Diabetes & Metabolic Syndrome
• Hyperglycemia/Hypoglycemia
• Diabetes & Endocrinology Clinical Trials

Efficacy and safety data from the Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus: Assessment of Weekly Administration of LY2189265 in Diabetes-3 study [AWARD-3; NCT01126580] Phase 3, randomized, double-blind, parallel-arm, monotherapy study have revealed the superiority of once-weekly dulaglutide 0.75 or 1.5 mg compared with twice-daily metformin 1000 mg in controlling glycemia in type 2 diabetes. The AWARD-3 results were presented by Santiago Tofé Povedano, MD, Clinica Juaneda, Palma de Mallorca, Spain.

Dulaglutide is a long-acting glucagon-like peptide-1 receptor agonist. The study compared two doses of dulaglutide administered once weekly to metformin administered twice daily in 807 patients with early type 2 diabetes (mean duration 2.6 years). Prior to inclusion in this study, the patients had been treated by diet and exercise alone or along with a low dose of an oral antidiabetic drug taken for ≥3 months.

The primary hypothesis was that dulaglutide 1.5 mg is noninferior to metformin with respect to the change in HbA1C from baseline to 26 weeks. Secondary hypotheses of note were that the higher dose of dulaglutide (1.5 mg) is superior to metformin and that the lower dulaglutide dose (0.75 mg) is noninferior and/or superior to metformin.

The results at 26 and 52 weeks in the intention-to-treat population are summarized in Table 1. In terms of the change in HbA1C from baseline, both dulaglutide doses and the higher dose were superior to metformin at 26 weeks and 52 weeks, respectively.

The incidence of adverse events was 6.0% for metformin, which was less than the rate (7.4%) of the dulaglutide 0.75 mg, but greater than the rate (5.2%) of the dulaglutide 1.5 mg. Gastrointestinal-related adverse events occurred frequently for patients treated with dulaglutide 1.5 mg, followed by metformin, followed by dulaglutide 0.75 mg. At 52 weeks, the percentage of patients with systematic hypoglycemia (defined as <3.9 mmol/L) was 6.3% for those receiving the higher dose of dulaglutide, 5.9% for those receiving the lower dose of dulaglutide, and 4.9% for those receiving metformin (overall p=0.756) [Tofé Povedano S et al. EASD 2013 (abstr 4)].

The findings demonstrated the superior glycemic control of both doses of dulaglutide given once-a-week compared with metformin administered twice each day. In addition, dulaglutide was well tolerated.

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