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Drug therapy for T2DM

IDegLira results show superior glycaemic control

Trial designed to evaluate the contribution of the liraglutide component of IDegLira on glycaemic control.

New phase 3 data from the DUal Action of Liraglutide and Insulin Degludec in Type 2 Diabetes (DUAL) II trial shows that in comparison with insulin degludec, IDegLira (insulin degludec [Tresiba]/liraglutide injection [Victoza]), achieved superior control of blood sugar levels (HbA1c), improved fasting and postprandial plasma glucose levels.

The rate of hypoglycaemia was low in both treatment groups, even with a significant difference in HbA1c reduction with IDegLira. The trial was designed to evaluate the contribution of the liraglutide component of IDegLira on glycaemic control.

IDegLira is the first-ever once-daily, single administration combination of a long-acting basal insulin and glucagon-like peptide 1 (GLP-1) analogue being developed by Novo Nordisk. IDegLira is a combination of insulin degludec (Tresiba), a once-daily basal insulin analogue with an ultra-long duration of action, and liraglutide (Victoza), the once-daily human GLP-1 analogue for the treatment of type 2 diabetes, which is being developed for the treatment of type 2 diabetes.

"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 2.7kg for patients uncontrolled on basal insulin,” said Professor John Buse, University of North Carolina School of Medicine, Chapel Hill, NC. “To achieve this, with a low rate of hypoglycaemia and few gastrointestinal adverse effects, is fantastic for this patient population,"

The DUAL II trial evaluated IDegLira in people with type 2 diabetes who were uncontrolled on basal insulin at 26 weeks.

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 (p<0.0001) at equivalent insulin doses. This resulted in people on IDegLira reaching an HbA1c of 6.9% at the end of the trial from a baseline of 8.7%.

Patients with type 2 diabetes on IDegLira experienced a significant mean weight loss of 2.7kg from baseline compared with no weight change with insulin degludec (p<0.0001).

Hypoglycaemia incidence was comparable between the two groups (24% for IDegLira vs 25% for insulin degludec), demonstrating that with IDegLira, superior glycaemic control was achieved in comparison with insulin degludec at equivalent insulin doses, with no higher risk of hypoglycaemia. The rates of confirmed hypoglycaemic events per person were 1.5 for IDegLira vs 2.6 for insulin degludec (p=0.13).

IDegLira also provided glycaemic control by reducing both fasting plasma glucose (FPG) and postprandial plasma glucose (PPG). Nine-point glucose profiles revealed significantly lower mean plasma glucose with IDegLira, compared with insulin degludec (7.5 vs 8.7mmol/L, respectively; estimated treatment difference: - 1.07mmol/L, p<0.0001).

IDegLira was well tolerated with a discontinuation rate of 1.0% at the end of treatment due to any adverse events in DUAL II.

None of the people taking IDegLira who had previously been on basal insulin discontinued due to nausea. Overall, gastrointestinal events were low and only marginally higher with IDegLira compared with insulin degludec (nausea 6.5% vs 3.5%; vomiting 3.5% vs 0.0%).

Novo Nordisk submitted the regulatory filing for IDegLira in the EU on 31 May 2013.

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