Dulaglutide significantly improves A1C (average blood sugar concentration over two to three months) when added to ongoing treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, according to results from AWARD-10, a new Phase 3b clinical study.1 These data were published online first in The Lancet Diabetes & Endocrinology.
“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,” says Bernhard Ludvik, M.D., associate professor of medicine, Rudolfstiftung Hospital Vienna and AWARD-10 lead author. “The AWARD-10 results suggest that the combination of once-weekly [dulaglutide] 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 percent, -1.21 percent for dulaglutide 1.5 mg and 0.75 mg, respectively) compared to an SGLT-2 inhibitor with placebo (-0.54 percent). Further, significantly more people in the dulaglutide groups reached target A1C levels of less than 7 percent and less than or equal to 6.5 percent:
- Dulaglutide 1.5 mg: 71 percent (<7 percent); 50 percent (≤6.5 percent)
- Dulaglutide 0.75 mg: 60 percent (<7 percent); 38 percent (≤6.5 percent)
- Placebo: 32 percent (<7 percent); 14 percent (≤6.5 percent)
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 percent, 5 percent, 4 percent), vomiting (4 percent, 3 percent, 1 percent) and diarrhea (6 percent, 10 percent, 3 percent) 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.
“Managing type 2 diabetes with diet, exercise and oral medications may require the addition of injectable therapy for some people, given the progressive nature of the disease,” says Brad Woodward, MD, senior medical director of Lilly Diabetes, who is marketing the drug as Trulicity. “AWARD-10 showed that Trulicity, when used in combination with an SGLT-2 inhibitor and metformin, may be effective and well tolerated in people with type 2 diabetes.”
About the AWARD-10 Study
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 sodium glucose co-transporter-2 (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 percent, was to demonstrate superiority of dulaglutide plus an SGLT-2 inhibitor to placebo plus an SGLT-2 inhibitor on A1C reduction.
Loading ...