Positive opinion on the usage of Levemir® (insulin detemir) as add-on therapy to Victoza® (liraglutide) in people with type 2 diabetes

The European Committee for Medicinal Products for Human Use (CHMP) has 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 has 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 CHMP’s opinion is based on data from a randomised, open-label, 52-week clinical trial conducted to evaluate the safety and efficacy of adding once-daily Levemir® to treatment with Victoza® 1.8 mg plus metformin.

“We are pleased with the positive opinion from the CHMP on the usage of Levemir® as add-on to Victoza® in combination with metformin. The trial demonstrated that adding once-daily Levemir® to Victoza® plus metformin results in additional reductions in HbA1c to patients who had not responded to metformin plus Victoza® alone, with a low risk of hypoglycaemia and sustained weight loss. This decision provides additional treatment options for patients who need more than Victoza® and metformin to achieve personalised glucose targets. As per recommendation from the CHMP we also are pleased to include the trial results in the product information for Victoza® based on the importance of this information for healthcare professionals,” says Alan Moses, global chief medical officer at Novo Nordisk.

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.

About the clinical trial ‘Adding Levemir® to Victoza®’

The 52-week, randomised, 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.

In the initial 12-week run-in period, patients were treated with Victoza® and metformin. During the following 26 weeks, patients achieving HbA1C <7% 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 or continue with Victoza® and metformin. This phase was then followed by a 26-week extension period.

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 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
• 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

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.