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Lookup NU author(s): Emeritus Professor Philip Home
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OBJECTIVE-To examine the efficacy and safety of adding the once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) lixisenatide to established basal insulin therapy alone or together with metformin, in people with type 2 diabetes and elevated glycated hemoglobin (HbA(1c)). RESEARCH DESIGN AND METHODS-We conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) with established basal insulin therapy but inadequate glycemic control were randomized to add lixisenatide 20 g or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA(1c) reduction from baseline was the primary end point. RESULTS-Mean duration of diabetes was 12.5 years, duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and baseline HbA(1c) was 8.4%. With lixisenatide, the placebo-corrected change of HbA(1c) from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA(1c) at end point was 7.8%. HbA(1c) <7.0% (53 mmol/mol) was attained by more lixisenatide (28%) than placebo (12%; P < 0.0001) participants. Lixisenatide reduced plasma glucose levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; P < 0.0001); seven-point glucose profiles showed a reduction persisting through the day. Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide. Main adverse events (AEs) with lixisenatide were gastrointestinal. Symptomatic hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo. CONCLUSIONS-By improving HbA(1c) and postprandial hyperglycemia without weight gain in type 2 diabetes with inadequate glycemic control despite stable basal insulin, lixisenatide may provide an alternative to rapid-acting insulin or other treatment options.
Author(s): Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J
Publication type: Article
Publication status: Published
Journal: Diabetes Care
Year: 2013
Volume: 36
Issue: 9
Pages: 2489-2496
Print publication date: 29/04/2013
ISSN (print): 0149-5992
ISSN (electronic): 1935-5548
Publisher: American Diabetes Association
URL: http://dx.doi.org/10.2337/dc12-2454
DOI: 10.2337/dc12-2454
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