Dulaglutide (Trulicity, Eli Lilly and Company) significantly improved HbA1C when added to ongoing type-2 diabetes treatment with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, according to results from the phase 3b AWARD-10 trial. The data were published online in The Lancet Diabetes & Endocrinology and released by Lilly.
Dulaglutide is a once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist approved to improve blood glucose in adults with type-2 diabetes.
"I've seen in my practice that even with effective oral medicines like SGLT-2 inhibitors and metformin, many adults with type-2 diabetes may still need additional therapy to maintain their blood sugar levels," said Bernhard Ludvik, MD, Associate Professor of Medicine, Rudolfstiftung Hospital Vienna, and AWARD-10 lead author. "The AWARD-10 results suggest that the combination of once-weekly Trulicity and an SGLT-2 inhibitor shows significant promise in helping more people with type-2 diabetes reach their treatment goals."
At the study's primary endpoint of 24 weeks, both dulaglutide 1.5 mg and 0.75 mg added to ongoing treatment with an SGLT-2 inhibitor demonstrated statistically superior glycemic control (–1.34%, –1.21% for dulaglutide 1.5 mg and 0.75 mg, respectively) compared to an SGLT-2 inhibitor with placebo (–0.54%).
Further, significantly more people in the dulaglutide groups reached target A1C levels of less than 7% and less than or equal to 6.5%: dulaglutide 1.5 mg: 71% (less than 7%), 50% (less than or equal to 6.5%); dulaglutide 0.75 mg: 60% (less than 7%), 38% (less than or equal to 6.5%); placebo: 32% (less than 7%), 14% (less than or equal to 6.5%).
Additional results showed that dulaglutide 1.5 mg combined with an SGLT-2 inhibitor was associated with greater average weight loss (–3.1 kg) compared to placebo (–2.1 kg). An average weight reduction of –2.6 kg was seen in the dulaglutide 0.75 mg group.
The most commonly reported adverse events associated with dulaglutide were gastrointestinal-related and consistent with previous studies. Nausea (15%, 5%, 4%), vomiting (4%, 3%, 1%) and diarrhea (6%, 10%, 3%) were more frequent in the dulaglutide 1.5 mg and 0.75 mg groups compared to placebo. One severe hypoglycemic event was documented in the dulaglutide 0.75 mg group. No new dulaglutide-related safety concerns were identified.
The phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week AWARD-10 study compared the safety and efficacy of dulaglutide 1.5 mg and 0.75 mg in combination with SGLT-2 inhibitors to placebo plus SGLT-2 inhibitors in people with type-2 diabetes inadequately controlled with SGLT-2 inhibitors, with or without metformin. The primary objective of this study, in 424 patients in eight countries with a mean baseline A1C of 8.04%, was to demonstrate superiority of dulaglutide plus an SGLT-2 inhibitor to placebo plus an SGLT-2 inhibitor on A1C reduction.
Source: Eli Lilly; February 26, 2018.