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Featured Article :. 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).
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Featured Article: 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) 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
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
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
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
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