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Dulaglutide Superior to Insulin Glargine in Phase III Trials

Treatment reduces hemoglobin with lower risk of hypoglycemia

Two pivotal phase III studies have shown that treatment with once-weekly dulaglutide (Eli Lilly) resulted in superior reductions in hemoglobin A1c (HbA1c) from baseline compared with insulin glargine, with a lower risk of hypoglycemia.

Dulaglutide is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist being studied for the treatment of type-2 diabetes. The results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco.

The AWARD-2 trial evaluated the safety and efficacy of two doses of once-weekly dulaglutide (0.75 and 1.5 mg) compared with insulin glargine as an add-on to combination therapy with sulfonylurea and metformin. The results showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more patients treated with dulaglutide 1.5 mg reached target HbA1c levels of less than 7%. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with sustained weight loss, whereas patients treated with insulin glargine experienced weight gain.

The AWARD-4 trial — the first study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin — showed that once-weekly dulaglutide (0.75 and 1.5 mg) combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared with the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7%, and patients treated with the dulaglutide-mealtime insulin lispro combination received 30% less total insulin dose. Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with a relative weight benefit compared with the basal/bolus therapy of insulin glargine and mealtime insulin lispro.

In both studies, hypoglycemia rates were lower in patients treated with dulaglutide 1.5 mg compared with those given insulin glargine. In the AWARD-2 trial, the 0.75-mg dose also had a lower rate of hypoglycemia compared with insulin glargine.

Adverse events were similar for the dulaglutide-treated patients in both studies. The most frequently reported adverse events were gastrointestinal-related, including nausea, diarrhea, and vomiting.

Once-weekly dulaglutide has been submitted to the FDA as a treatment for type-2 diabetes. Five AWARD registration trials were included in the regulatory package.

If approved, dulaglutide will be marketed under the brand name Trulicity.

Source: Eli Lilly; June 16, 2014.

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