alexa Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M).
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Developing Drugs

Author(s): Ahrn B, Leguizamo Dimas A, Miossec P, Saubadu S, Aronson R

Abstract Share this page

Abstract OBJECTIVE: To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone. RESEARCH DESIGN AND METHODS: This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (HbA1c 7-10\% [53-86 mmol/mol]). Patients were randomized to lixisenatide morning (n = 255), lixisenatide evening (n = 255), placebo morning (n = 85), or placebo evening (n = 85) injections. RESULTS: Lixisenatide morning injection significantly reduced mean HbA1c versus combined placebo (mean change -0.9\% [9.8 mmol/mol] vs. -0.4\% [4.4 mmol/mol]; least squares [LS] mean difference vs. placebo -0.5\% [5.5 mmol/mol], P < 0.0001). HbA1c was significantly reduced by lixisenatide evening injection (mean change -0.8\% [8.7 mmol/mol] vs. -0.4\% [4.4 mmol/mol]; LS mean difference -0.4\% [4.4 mmol/mol], P < 0.0001). Lixisenatide morning injection significantly reduced 2-h postprandial glucose versus morning placebo (mean change -5.9 vs. -1.4 mmol/L; LS mean difference -4.5 mmol/L, P < 0.0001). LS mean difference in fasting plasma glucose was significant in both morning (-0.9 mmol/L, P < 0.0001) and evening (-0.6 mmol/L, P = 0.0046) groups versus placebo. Mean body weight decreased to a similar extent in all groups. Rates of adverse events were 69.4\% in both lixisenatide groups and 60.0\% in the placebo group. Rates for nausea and vomiting were 22.7 and 9.4\% for lixisenatide morning and 21.2 and 13.3\% for lixisenatide evening versus 7.6 and 2.9\% for placebo, respectively. Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes. CONCLUSIONS: In patients with type 2 diabetes inadequately controlled on metformin, lixisenatide 20 μg once daily administered in the morning or evening significantly improved glycemic control, with a pronounced postprandial effect, and was well tolerated. TRIAL REGISTRATION: NCT00712673.
This article was published in Diabetes Care and referenced in Journal of Developing Drugs

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version