A potential new treatment option for T2 diabetes….
Novo Nordisk continues their testing of the new combination drug, IDegLira, a fixed ratio injectable combination of insulin degludec (Tresiba, Novo Nordisk) and liraglutide (Victoza, Novo Nordisk), a GLP-1 receptor agonist (1 unit of insulin degludec is combined with 0.036 mg of liraglutide). Findings from their phase III study, Dual II, were presented at the World Diabetes Congress 2013 in early December. There were 413 participants included in the randomized, double-blind, parallel arm multi-center study carried out over a 26 week period in which treatment with IDegLira was compared to insulin degludec alone in patients who were inadequately controlled on basal insulin plus a 1-2 oral anti-diabetic agent regimen. The primary outcome measure was change in HbA1C from baseline and a secondary outcome measure of change in body weight was also assessed.
The efficacy of IDegLira had already been assessed in Novo Nordisk’s phase II study, Dual I, in which IDegLira was found to be superior to liraglutide alone and non-inferior to insulin alone. Researchers reported that treatment with IDegLira led to improved glycemic control, significant weight loss and less hypoglycemia as compared to insulin degludec alone; IDegLira also had only a minimally higher reported GI side effect of nausea at 7% as compared to 4% in the insulin alone group. Although the specifics on the results are yet to published, this combination drug may be of benefit to patients who have poorly controlled type 2 diabetes. Since currently all of the GLP-1 agonists are injectable, Byetta, Bydureon and Victoza, a mix with insulin could limit the amount of injections they would be taking in a day. The maximum dosage that IDegLira will be available in is 50 units of insulin degludec with 1.8 mg of liraglutide.
Insulin degludec has not yet received approval from the FDA. Early in 2013, the FDA told Novo NorDisk that they need to complete large-scale cardiovascular studies on insulin degludec before approval. Insulin degludec is an ultra-long acting basal insulin with duration of action up to 42 hours. It has been approved for use in Europe, Japan, Iceland, India, Mexico, Norway, and Switzerland.
- IDegLira is a proposed new drug by Novo NorDisk which comes in a fixed, single injectable combination of insulin degludec and liraglutide (1 unit of insulin degludec is combined with 0.036 mg of liraglutide).
- Results from the phase III study comparing IDegLira to insulin degludec alone shows promise with improved glycemic control, significant weight loss and less hypoglycemia.
- Insulin degludec is an ultra-long acting insulin with reported duration of action up to 42 hours and has not received FDA approval in the U.S.
A 26-week randomized, parallel two-arm, double-blind, multi-centre, multinational, treat-to-target trial comparing fixed ratio combination of insulin degludec and liraglutide with insulin degludec in subjects with type 2 diabetes. Novo Nordisk Trial ID: NN9068-3912. Results presented at World Diabetes Congress 2013 by Dr. Stephen Gough, MD