In adults with diabetes on metformin, HbA1c fell by 0.96% with exenatide versus 0.79% with lixisenatide, and lixisenatide met the noninferiority margin.
In plain wordsIn adults with diabetes, HbA1c fell with both drugs, and lixisenatide met noninferiority criteria versus exenatide.
- Peptide
- Exenatide (exendin-4)
- Outcome
- DecreaseHbA1c change
- Study
n = 634
- Comparator
- Lixisenatide once daily
- Analysis
- Primary
- Outcome group
- Glycemic control · Metabolic and weight
- Studied dose
- 10 μg twice daily · 24 weeksAs given in this study (human).
Measurements
- HbA1c least squares mean change
- −0.96%
- exenatide
- HbA1c least squares mean change
- −0.79%
- lixisenatide
- HbA1c treatment difference (lixisenatide versus exenatide)
- 0.17%
- lixisenatide versus exenatide
Source sentences
The least squares mean change was -0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus -0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033-0.297), meeting a predefined noninferiority upper CI margin of 0.4%.
2 context sentences(design, population, supporting numbers)
The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 24.
Adults with diabetes inadequately controlled (HbA1c 7-10%) with metformin were randomized to lixisenatide 20 μg once daily (n=318) or exenatide 10 μg twice daily (n=316) in a 24-week (main period), open-label, parallel-group, multicenter study.