Abstract | AIMS: METHODS: This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24. RESULTS: In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups ( lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups ( lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period. CONCLUSIONS:
Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.
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Authors | M Pinget, R Goldenberg, E Niemoeller, I Muehlen-Bartmer, H Guo, R Aronson |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 15
Issue 11
Pg. 1000-7
(Nov 2013)
ISSN: 1463-1326 [Electronic] England |
PMID | 23627775
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2013 John Wiley & Sons Ltd. |
Chemical References |
- GLP1R protein, human
- Glucagon-Like Peptide-1 Receptor
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Peptides
- Receptors, Glucagon
- Thiazolidinediones
- hemoglobin A1c protein, human
- lixisenatide
- Metformin
- Pioglitazone
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Topics |
- Aged
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Drug Monitoring
- Drug Resistance
- Drug Therapy, Combination
(adverse effects)
- Female
- Glucagon-Like Peptide-1 Receptor
- Glycated Hemoglobin
(analysis)
- Humans
- Hyperglycemia
(prevention & control)
- Hypoglycemia
(prevention & control)
- Hypoglycemic Agents
(administration & dosage, adverse effects, therapeutic use)
- Intention to Treat Analysis
- Male
- Metformin
(adverse effects, therapeutic use)
- Middle Aged
- Patient Dropouts
- Peptides
(administration & dosage, adverse effects, therapeutic use)
- Pioglitazone
- Receptors, Glucagon
(agonists)
- Thiazolidinediones
(adverse effects, therapeutic use)
- Weight Loss
(drug effects)
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