The US Food and Drug Administration (FDA) has approved to update the product label for Novo Nordisk's Victoza (liraglutide [rDNA] injection) to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin).
The update also includes data demonstrating the safety and efficacy of adding basal insulin to Victoza and metformin for the treatment of adults with type 2 diabetes.
The label update is based on data from two large, randomized, open-label studies in adults with type 2 diabetes. “The data from these studies further demonstrate the strong clinical profile and the value of Victoza in the treatment of type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The 26-week randomized open label clinical trial was conducted to evaluate the safety and efficacy of Victoza 1.2 mg and 1.8 mg plus metformin compared to Januvia plus metformin. Patients treated with 1.2 mg and 1.8 mg of Victoza experienced greater reductions in HbA1C than those treated with Januvia 100 mg tablets (-1.2% and -1.5% versus -0.9%).
Victoza furthermore provided greater weight loss versus patients treated with Januvia (2.7 kg [5.94 lbs] and 3.3 kg [7.26 lbs] for 1.2 mg and 1.8 mg respectively, 0.8 kg [1.76 lbs] for Januvia).
The 26-week, randomised, open-label clinical trial was conducted to evaluate the safety and efficacy profile of adding once-daily Levemir (insulin detemir) to treatment with Victoza 1.8 mg plus metformin.
In the initial 12-week run-in period, patients were treated with Victoza and metformin. After completing the 12 week run-in treatment, 50% of patients reached the ADA target for blood sugar control (HbA1C<7%).
During the following 26 weeks, patients achieving HbA1C <7% in the run-in period remained on the same regimen in an observational group while the remaining patients were randomised to either add Levemir to the existing Victoza and metformin regimen or continue with Victoza and metformin.
After 26 weeks, patients randomised to add on Levemir to Victoza and metformin had further HbA1C reductions of 0.5%, while HbA1C remained stable in the Victoza and metformin group. At 26 weeks, 43% of patients in the Victoza, metformin and Levemir group reached the ADA target for blood sugar control (HbA1C <7%) vs. an additional 17% in the Victoza and metformin group. Patients did not gain weight after Levemir was added.
The proportion of patients reporting adverse events for the entire trial period was comparable between the two randomised treatment groups and the non-randomised treatment group. There was no specific pattern or clustering of serious adverse events and the most commonly reported events were common infections and nausea.
Victoza (liraglutide) is the first and only human GLP-1 analogue (glucagon-like peptide-1) that is 97 per cent similar to endogenous human GLP-1. Like natural GLP-1, Victoza works by stimulating the beta cells to release insulin only when blood sugar levels are high.
Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.