Label change of liraglutide demonstrates superiority compared to sitagliptin
FDA approved an update to the product label of liraglutide [rDNA] injection (Victoza, Novo Nordisk), which includes data demonstrating superior blood sugar control and weight reduction when compared with sitagliptin (Januvia, Merck), according to a press release from Novo Nordisk.
The updated label also includes data showing the safety and efficacy of the addition of basal insulin to liraglutide and metformin for the treatment of adults with type 2 diabetes, the company reported.
The label update is based on data from 2 large, randomized, open-label studies in adults with type 2 diabetes. “The data from these studies further demonstrate the strong clinical profile and value of Victoza in the treatment of type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
In the first study, the safety and efficacy of liraglutide 1.2 mg and 1.8 mg plus metformin was compared with sitagliptin plus metformin during a 26-week clinical trial. Patients treated with either dose of liraglutide experienced greater reduction in HbA1C than patients who received sitagliptin 100 mg tablets (-1.2% and -1.5% vs. -0.9%). In addition, liraglutide provided greater weight loss (2.7 kg and 3.3 kg for 1.2 mg and 1.8 mg, respectively) than sitagliptin (0.8 kg).
In the second study, the safety and efficacy of the addition of insulin detemir (Levemir, Novo Nordisk) to liraglutide 1.8 mg plus metformin was evaluated over 26 weeks. An initial 12-week run-in period, patients received liraglutide and metformin. After completing the 12-week treatment, half of the patients reached their target for blood sugar control (HbA1C
At 26 weeks, patients who received the addition of insulin detemir had further HbA1C reductions of 0.5%, with 43% achieving their target for blood sugar control. Only an additional 17% of those who didn’t receive the insulin detemir reached their HbA1C target goals.