European Committee for Medicinal Products for Human (CMPH) Use issued a positive opinion on the use of insulin Levemir base as adjunctive therapy to analog (GLP-1) Victoza in combination with metformin in patients with type 2 diabetes
The Committee also issued a positive opinion for the Victoza product. Although the study does not consider the results sufficient to support a new therapeutic indication for the drug, the Committee concluded that the new data are important for health professionals related to the treatment of type 2 diabetes, and recommended, to place new data in the Summary of Product Characteristics (SPC) of the product.
Decision Committee based on data from a randomized, open, 52-week clinical trial conducted to assess the safety and efficacy of adding insulin Levemir given once daily by injection, for treatment with Victoza dose of 1.8 mg of metformin.
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