Following a review of new data from a 52-week clinical trial, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the usage of Novo Nordisk’s basal insulin analogue, Levemir, as add-on therapy to Novo Nordisk’s GLP-1 analogue, Victoza, in combination with metformin in patients with type 2 diabetes.
The CHMP also adopted a positive opinion for Victoza. Although the CHMP did not consider the results of the study sufficient to support a new indication for Victoza, the Committee concluded that the new data were of importance to healthcare professionals involved in treating type 2 diabetes and recommended that they be included in the product information for Victoza.
The 52-week, randomized, open-label clinical trial was conducted to evaluate the safety and efficacy of adding once-daily Levemir to treatment with Victoza 1.8 mg plus metformin.
Key findings from the study include:
- After completing 12 weeks of treatment with Victoza and metformin, 61% of patients reached the ADA target for blood sugar control (HbA1C <7%) with mean decreases in HbA1C of 1.3% and body weight of 4.4 kg (9.7 lbs)
- After the additional 26 weeks, patients randomized 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
- Furthermore, 43% of patients in the Victoza, metformin and Levemir group reached the ADA target for blood sugar control (HbA1C <7%) at 26 weeks vs an additional 17% in the Victoza and metformin group
- Weight loss was sustained after Levemir was added.
Novo Nordisk anticipates that the European Commission, within the coming months, will approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes.