Meta-Analysis of Randomized Controlled Trials of Lixisenatide as Add On to Basal Insulin and/or Oral Antihyperglycemic Agents in Patients with Type 2 Diabetes Mellitus

Abstract

To evaluate the safety and efficacy of lixisenatide in combination with basal insulin ± oral antihyperglycemic agents in patients with type 2 diabetes mellitus (T2DM). This was a meta-analysis of 1198 patients from 3 phase III, randomized, placebo-controlled trials from the lixisenatide clinical development program (GetGoal-L, GetGoal-Duo-1 and GetGoal-L-Asia). Mean baseline characteristics: age: 57.2 years; diabetes duration: 11.7 years; body mass index: 30.3 kg/m2; mean A1C was 8.2% for lixisenatide vs. 8.1% for placebo. At endpoint, mean A1C was 7.5% vs. 7.9% for lixisenatide and placebo, respectively. A significantly higher proportion of lixisenatide patients achieved A1C <7% vs. placebo (odds ratio [95% CI]: 3.7 [1.6, 8.2], p=0.0016). Lixisenatide was more than 3 times more likely than placebo to result in A1C <7% and no weight gain (odds ratio [95% CI]: 3.4 [1.7, 6.8], p=0.0008), more than 2.5 times more likely than placebo to result in A1C <7% and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.7 [1.3, 5.4], p=0.0073) and more than 2.5 times more likely to result in A1C <7% and no weight gain and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.6 [1.5, 4.7], p=0.0009). In patients with T2DM, lixisenatide in combination with basal insulin ± antihyperglycemic agents is significantly more effective than placebo in achieving A1C <7%, and is more than 2.5 times more likely to result in A1C <7% with no documented hypoglycemia and no weight gain. Lixisenatide is a treatment option as add on to treatment with basal insulin.