July 15, 2014
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Weekly dulaglutide HbA1c control, safety similar to daily liraglutide

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Once-weekly treatment with dulaglutide proved to be equally effective and safe in controlling HbA1c and hypoglycemia in patients with type 2 diabetes as once-daily liraglutide, according to research published in The Lancet.

Both glucagon-like peptide-1 receptor agonists produced similar results in least-squares mean reduction in HbA1c among 599 patients with inadequately controlled type 2 diabetes already receiving at least 1,500 mg metformin daily with comparable tolerability.

In phase 3 of the open-label, parallel-group AWARD-6 study at 62 sites in nine countries, Kathleen M. Dungan, MD, MPH, of The Ohio State University in Columbus, and colleagues evaluated patients (aged ≥18 years, HbA1c ≥7% and ≤10%, BMI=45) randomly assigned to treatment

Kathleen Dungan

Kathleen M. Dungan

A computer-generated sequence with interactive voice response system assigned 299 patients to receive once-weekly dulaglutide (1.5 mg; Eli Lilly and Company) and 300 patients to receive once-daily liraglutide (1.8 mg; Victoza, Novo Nordisk); neither participants nor investigators were masked to treatments. Noninferiority was measured by a margin of 0.4% change in HbA1c from baseline to 26 weeks, with safety data collected after an additional 4 weeks.

Least-squares mean reduction in HbA1c in the dulaglutide group was –1.42% vs. –1.36% in the liraglutide group. The mean treatment difference in HbA1c between groups demonstrated non-inferiority at −0.06% (95% CI, −0.19 to 0.07).

Common gastrointestinal adverse events reported were nausea (20% with dulaglutide group vs. 18% with liraglutide), diarrhea (12% vs. 12%), dyspepsia (8% vs. 6%) and vomiting (7% vs. 8%). Study discontinuation due to adverse events was 6% in each group.

The rate of hypoglycemic events per patient per year was 0.34 with dulaglutide and 0.52 with liraglutide; no severe hypoglycemia was reported.

Disclosure: The study was funded by Eli Lilly and Company; some researchers report consulting and advisory board activities with the company, receiving lecture honoraria or speaker fees from them, or being employed by them. One researcher reports receiving research support from Novo Nordisk.