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Monotherapy with the investigational GLP-1 receptor antagonist lixisenatide significantly reduces postprandial glucose excursions and HbA1c in treatment-naive type 2 diabetes patients….
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.”
Diabetes Care March 19, 2012