Abstract | OBJECTIVE: 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 μg or placebo for 24 weeks. Basal insulin dosage was unchanged except to limit hypoglycemia. HbA1c 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 HbA1c was 8.4%. With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%. HbA1c <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:
|
Authors | Matthew C Riddle, Ronnie Aronson, Philip Home, Michel Marre, Elisabeth Niemoeller, Patrick Miossec, Lin Ping, Jenny Ye, Julio Rosenstock |
Journal | Diabetes care
(Diabetes Care)
Vol. 36
Issue 9
Pg. 2489-96
(Sep 2013)
ISSN: 1935-5548 [Electronic] United States |
PMID | 23628617
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Hypoglycemic Agents
- Insulin
- Peptides
- lixisenatide
|
Topics |
- Aged
- Diabetes Mellitus, Type 2
(drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage, therapeutic use)
- Insulin
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Peptides
(administration & dosage, therapeutic use)
|