Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X).

Abstract

OBJECTIVE:

To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin.

RESEARCH DESIGN AND METHODS:

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. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 24.

RESULTS:

Lixisenatide once daily demonstrated noninferiority in HbA1c reduction versus exenatide twice daily. 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%. Responder rate (HbA1c<7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P<0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P<0.05).

CONCLUSIONS:

Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA1c, with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily.

• Authors: Julio Rosenstock, Denis Raccah, László Korányi, Laura Maffei, Gabor Boka, Patrick Miossec, John E Gerich
• Journal: Diabetes care (Diabetes Care) Vol. 36 Issue 10 Pg. 2945-51 (Oct 2013) ISSN: 1935-5548 [Electronic] United States
• PMID: 23698396 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hypoglycemic Agents
• Peptides
• lixisenatide
• Metformin

Topics

• Adult
• Aged
• Aged, 80 and over
• Diabetes Mellitus, Type 2 (drug therapy)
• Drug Administration Schedule
• Female
• Humans
• Hypoglycemic Agents (administration & dosage, therapeutic use)
• Male
• Metformin (administration & dosage, therapeutic use)
• Middle Aged
• Peptides (administration & dosage, therapeutic use)
• Treatment Outcome
• Young Adult