Dulaglutide Superior to Placebo when Added to a Sodium Glucose Cotransporter-2 Inhibitor

February 23, 2018. The Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes-10 (AWARD-10) trial, a 24-week, phase 3b, double-blind, parallel-arm, placebo-controlled study, found the glucagon-like peptide-1 receptor agonist dulaglutide 1.5 mg (n=142) and 0.75 mg (n=142) significantly superior to placebo (n=140) in lowering A1C when added to any sodium glucose cotransporter-2 (SGLT-2) inhibitor, with or without metformin, in patients with uncontrolled type 2 diabetes. Least squares mean (LSM) reductions in A1C for those receiving dulaglutide 1.5 mg and 0.75 mg were 1.34% (standard error [SE]: 0.06) and 1.21% (SE: 0.06), respectively, vs -0.54% (SE: 0.06) for placebo (P<0.0001 for both dulaglutide groups vs placebo). For dulaglutide 1.5 mg and 0.75 mg, the LSM differences vs placebo were, respectively, -0.79% (95% confidence interval [CI]: -0.97 to -0.61) and −0.66% (95% CI: -0.84 to -0.49; P<0.0001 for both). Treatment-emergent adverse events, especially gastrointestinal adverse events, were more common among patients in the dulaglutide groups, but at a rate typical of dulaglutide’s established safety profile. Thus, dulaglutide is safe and effective when added to an SGLT-2 inhibitor, with or without metformin. You can read the study abstract here.