1. 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) Featured Article: Matthew C. Riddle, M.D., Thomas Forst, M.D., Ronnie Aronson, M.D., F.R.C.P.C., F.A.C.E., Leobardo Sauque-Reyna, M.D., Elisabeth Souhami, M.D., Louise Silvestre, M.D., Lin Ping, M.D., Julio Rosenstock, M.D. Diabetes Care Volume 36: 2497-2503 September, 2013

2. STUDY OBJECTIVE When oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial We examined the efficacy and safety of lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

3. STUDY DESIGN AND METHODS This double-blind, parallel-group trial enrolled patients with HbA1c of 7–10% despite oral therapy Insulin glargine was added and systematically titrated during a 12-week run-in After the run-in period, candidates with fasting glucose ≤7.8 mmol/L and HbA1c 7–9% were randomized to 20  g lixisenatide or placebo for 24 weeks while insulin titration continued Primary end point was HbA1c change after randomization Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

4. RESULTS Randomized population had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units HbA1c had decreased during run-in from 8.6 to 7.6% Adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40% with placebo More participants attained HbA1c <7% with lixisenatide Lixisenatide reduced plasma glucose 2 h after a standardized breakfast and had a favorable effect on body weight Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

8. CONCLUSIONS Adding lixisenatide to insulin glargine improved overall and postprandial hyperglycemia Lixisenatide should be considered as an alternative to prandial insulin for patients not reaching HbA1c goals with recently initiated basal insulin Riddle M. C. et al. Diabetes Care 2013;36:2497-2503