DURATION-8 Trial: Efficacy and Safety of Once-Weekly Exenatide Plus Once-Daily Dapagliflozin vs Exenatide or Dapagliflozin Alone

September 13, 2017. This 28-week double-blind, multicenter, randomized controlled trial evaluated the efficacy of once-weekly exenatide 2 mg (EXE) with or without dapagliflozin 10 mg (DAPA) in patients with type 2 diabetes inadequately controlled on metformin alone. Participants were randomized to receive EXE + DAPA, EXE + oral placebo, or DAPA + injected placebo; the study also included a 24-week extension phase. At 52 weeks, patients receiving EXE + DAPA had greater reductions in A1C levels, fasting plasma glucose, 2-hour postprandial glucose, body weight, and systolic blood pressure compared with the other groups. Across all patient groups, a similar proportion (~5%) experienced a serious adverse event (AE); the most common AEs overall (≥5% incidence) were diarrhea, headache, injection site reaction, nausea, and upper respiratory and/or urinary tract infection. Patients receiving EXE + DAPA were more likely to experience minor hypoglycemia (1.3% incidence, vs 0.0% and 0.4% for EXE + placebo and DAPA + placebo, respectively); no major hypoglycemic events were reported. These findings were presented at the European Association for the Study of Diabetes meeting. Follow this link to read the study abstract.