Lixisenatide Once-Daily GLP-1 Drug Effective for Type 2 Diabetes
Monotherapy with the investigational GLP-1 receptor antagonist lixisenatide significantly reduces postprandial glucose excursions and HbA1c in treatment-naive type 2 diabetes patients....
Advertisement
Dr. Vivian A. Fonseca, with Tulane University Health Sciences Center in New Orleans, Louisiana, and colleagues note that, "No other placebo-controlled studies are available for GLP-1 receptor agonist monotherapy in a similar patient population." They point out that while two other GLP-1 receptor agonists are currently on the market -- exenatide (Byetta, Bydureon) and liraglutide (Victoza) -- lixisenatide is highly selective for the GLP-1 receptor, and stimulation of insulin secretion with lixisenatide depends "strictly" on glucose levels.
In the current randomized double-blind, 12-week study, 361 drug-naive patients with type 2 diabetes and HbA1c levels between 7% and 10% were assigned to once-daily subcutaneous lixisenatide regimens that increased in dosage in two steps (10 mcg for1 week, 15 mcg for 1 week, and then 20 mcg) or in one step (10 mcg for 2 weeks and then 20 mg) or to similar placebo regimens.
The proportion of patients achieving an HbA1c <7% in the two lixisenatide groups was 52.2% and 46.5%, respectively, compared with 26.8% among those in the combined placebo groups. An HbA1c of 6.5% or less was achieved by 31.9%, 25.4% and 12.5% of the three arms, respectively, the investigators report.
They also found that compared to baseline, two-hour postprandial glucose levels fell by 81mg/dL and 98mg/dL.(4.51 and 5.47 mmol/L) in the two- and one-step lixisenatide groups compared with a drop of just 11mg/dL.(0.65 mmol/L) with placebo.
Each group lost an average of about two kg, indicating that the glucose-lowering effects of lixisenatide were not attributable to weight loss, the authors note.
As for safety, rates of symptomatic hypoglycemia were 1.7% in the lixisenatide groups and 1.6% in the placebo arms. Gastrointestinal side effects were relatively high with lixisenatide, with nausea being the most frequent (23% with lixisenatide vs 4.1% with placebo).
Dr. Fonseca and colleagues conclude, "The results support a role for once-daily lixisenatide monotherapy using a one-step dose increase regimen in patients not controlled on lifestyle interventions and highlight the potential of lixisenatide for further development as a glucose-lowering compound to treat patients with type 2 diabetes."
DISCLAIMER: The content of this Website is independent of the views of our advertisers and sponsors. The site is designed primarily for use by qualified physicians and other medical professionals. The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider. The information provided here is for educational and informational purposes only. In no way should it be considered as offering medical advice. Please check with a physician if you suspect you are ill.
Copyright @ 1999-2013 Diabetes In Control, Inc.. All rights reserved.
