Denmark-based Novo Nordisk has announced that a Phase III trial of its investigational therapy IDegLira showed better control of blood sugar levels (HbA1c) compared with its own long-acting insulin Tresiba.
IDegLira is a once-daily, single administration combination of insulin degludec (Tresiba) and Novo’s glucagon-like peptide-1 (GLP-1) diabetes drug Victoza.
GLP-1 drugs work by stimulating the release of insulin when blood sugar levels become too low.
In the Phase III study, also called as DUAL II trial, improved fasting and postprandial plasma glucose levels were observed with IDegLira throughout the day and across meals, while providing significant weight loss for adults with type 2 diabetes uncontrolled on basal insulin.
The DUAL II trial, which is aimed at assessing the contribution of the liraglutide component of IDegLira on glycaemic control, also showed that the rate of hypoglycaemia was low in both treatment groups, even with a significant difference in HbA1c reduction with IDegLira.
Hypoglycaemia incidence was comparable between the two groups (24% for IDegLira vs 25% for insulin degludec), showing that with IDegLira, superior glycaemic control was achieved in comparison with insulin degludec at equal insulin doses, with no higher risk of hypoglycaemia.
University of North Carolina School of Medicine professor John Buse said many patients are concerned about insulin-based therapies due to a fear of weight gain and hypoglycaemia.
"In the DUAL II trial, IDegLira demonstrated spectacular HbA1c reductions with a weight loss of 2.7 kg for patients uncontrolled on basal insulin," Buse said.
"To achieve this, with a low-rate of hypoglycaemia and few gastrointestinal adverse effects, is fantastic for this patient population."
The trial assessed IDegLira in people with type 2 diabetes who were uncontrolled on basal insulin at 26 weeks.
The company said that at 26 weeks, once-daily IDegLira provided a mean HbA1C reduction of 1.90% compared with a reduction of 0.89% for people taking insulin degludec at equivalent insulin doses.
DUAL (DUal Action of Liraglutide and Insulin Degludec in type 2 diabetes) includes two Phase IIIa trials encompassing around 2,000 people with type 2 diabetes.
Around 1,600 people have participated in the 26-week, randomised, open-label DUAL I trial comparing the efficacy and safety of IDegLira, insulin degludec and liraglutide, in people with type 2 diabetes inadequately controlled with metformin with or without pioglitazone.
The 26-week, randomised, double-blinded DUAL II trial compared IDegLira and insulin degludec in about 400 people with type 2 diabetes uncontrolled on basal insulin in combination with metformin ± sulphonylurea/glinides.
The Danish drugmaker submitted the regulatory filing for IDegLira in the EU on 31 May.