Liraglutide is a long-acting analog of glucagon-like-peptide-1 (GLP-1). Currently in phase 3 trials, this agent shows promise in the treatment of type 2 diabetes. A large, randomized, placebo controlled phase 2 trial was conducted in 165 patients with type 2 diabetes. Participants discontinued their previous medications and were randomized to either placebo or once-daily doses of 0.65 mg, 1.25 mg or 1.9 mg liraglutide. The primary outcome measure was the change in the baseline level of HbA1c at the final visit.

At Week 14, HbA1c levels in all 3 liraglutide groups were significantly lower compared to placebo (p<0.0001). This improvement in glycemic control was not associated with major or minor episodes of hypoglycemia. Patients taking liraglutide also had a decrease in body weight, with those in the 1.9 mg/day group losing approximately 3 kg vs. 1.2 kg on placebo after 14 weeks of treatment. The most common adverse events reported with liraglutide were nausea and diarrhea.

A subgroup of 39 patients was studied to determine first-phase insulin secretion and maximal beta cell insulin secretory capacity. Patients in the 1.25 mg/day and 1.9 mg/day groups had significantly higher maximal beta cell insulin secretory capacity and first phase insulin secretion when compared to placebo (all p<0.05). “We are excited by these results as they demonstrate that liraglutide monotherapy significantly improves blood glucose control without risk of major or minor hypoglycemia, is well-tolerated, lowers body weight, and may help improve the body's ability to produce insulin,” said study investigator Sten Madsbad, MD, DMSc of the University of Copenhagen.