Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled With Newly Initiated and Continuously Titrated Basal Insulin Glargine: A 24-Week, Randomized, Placebo-Controlled Study (GETGOAL-DUO-1)

TLDR: In this paper, the efficacy and safety of lixisenatide in patients with HbA 1c still elevated after initiation of insulin glargine were examined in a double-blind, parallel-group trial.

Abstract: OBJECTIVE When oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA 1c ) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of lixisenatide in patients with HbA 1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND METHODS This double-blind, parallel-group trial enrolled patients with HbA 1c 7–10% despite oral therapy. Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤7.8 mmol/L and HbA 1c 7–9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA 1c change after randomization. RESULTS The randomized population ( n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m 2 , and daily glargine dosage of 44 units. HbA 1c had decreased during run-in from 8.6 to 7.6%; adding lixisenatide further reduced HbA 1c by 0.71 vs. 0.40% with placebo (least squares mean difference, –0.32%; 95% CI, –0.46 to –0.17; P 1c P P P = 0.0012). Nausea, vomiting, and symptomatic hypoglycemia CONCLUSION Adding lixisenatide to insulin glargine improved overall and postprandial hyperglycemia and deserves consideration as an alternative to prandial insulin for patients not reaching HbA 1c goals with recently initiated basal insulin.