Trulicity + SGLT-2 inhibitor success in AWARD-10 study for type 2 diabetes.- Eli Lilly

Trulicity (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 IIIb clinical study. These data were published online first in The Lancet Diabetes & Endocrinology.

Trulicity is Eli Lilly and Company's once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor agonist approved to improve blood sugar (glucose) in adults with type 2 diabetes. Trulicity should be used along with diet and exercise. At the study's primary endpoint of 24 weeks, both Trulicity 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 Trulicity 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 Trulicity groups reached target A1C levels of less than 7 percent and less than or equal to 6.5 percent: Trulicity 1.5 mg: 71 percent ( < 7 percent); 50 percent (?6.5 percent). Trulicity 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 Trulicity 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 Trulicity 0.75 mg group. The most commonly reported adverse events associated with Trulicity 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 Trulicity 1.5 mg and 0.75 mg groups compared to placebo. One severe hypoglycemic event was documented in the Trulicity 0.75 mg group. No new Trulicity-related safety concerns were identified.

See_Ludvik, Bernhard, MD, Frias, Juan P., MD, et. al. "Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial". The Lancet Diabetes & Endocrinology. 2018: S2213-8587 (18) 30023-8. Retrieved from http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30023-8/fulltext?elsca1=tlxpr..