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Novo Nordisk A/S (NVO) Release: New One-year Data of IDegLira Shows Glucose-Lowering Effect Was Maintained For People With Type 2 Diabetes

6/16/2014 7:37:20 AM

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SAN FRANCISCO, Jun 14, 2014 (PR Newswire Europe via COMTEX) -- SAN FRANCISCO, June 14, 2014 /PRNewswire/ --

New Phase 3a findings show IDegLira, the investigational once-daily single injection combination of insulin degludec and liraglutide, for the treatment of people with type 2 diabetes, maintained its glucose-lowering effect and confirmed safety evaluations for up to one year.[1] Findings from the 26-week extension of the DUAL(TM) I clinical trial programme were presented today at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in

San Francisco, CA.

The DUAL(TM) I extension trial compared the efficacy and safety of IDegLira with insulin degludec and liraglutide 1.8 mg alone in insulin-naive adults with type 2 diabetes uncontrolled on metformin with or without pioglitazone. At 52 weeks, IDegLira demonstrated a statistically significant and sustained HbA1c (blood glucose) reduction of 1.8% from baseline versus 1.4% for insulin degludec and 1.2% for liraglutide (p<0.0001). The average HbA1c at the end of the trial was 6.4% for IDegLira, 6.9% with insulin degludec and 7.1% with liraglutide. Of the patients on IDegLira, 78% achieved an HbA1c goal of <7% versus 63% for insulin degludec and 57% for liraglutide. Mean fasting plasma glucose (FPG) was similar for IDegLira (103 mg/dl) and insulin degludec (108 mg/dl) and higher for liraglutide (132 mg/dl).[1]

"Maintaining glycaemic control as diabetes progresses is an ongoing problem as patients fear initiating new therapies that may increase the risk of side effects such as weight gain and hypoglycaemia," said Professor John Buse, University of North Carolina School of Medicine, Chapel Hill, North Carolina, U.S. "All of the IDegLira data presented here at ADA indicate that this treatment can address these patient concerns."

At the end of the trial, the IDegLira treatment group observed a mean weight reduction of 0.4 kg (0.9 lbs), which was consistent with the first 26 weeks of treatment. Patients taking insulin degludec had a weight gain of 2.3 kg (5.1 lbs) and patients on liraglutide had a weight reduction of 3.0 kg (6.6 lbs). The estimated treatment difference between IDegLira and insulin degludec was -2.8 kg (-6.1 lbs) and the relative treatment difference between IDegLira and liraglutide was 2.7 kg (5.9 lbs).[1]

The daily insulin dose for patients on IDegLira remained stable throughout the extension phase (39 units) compared with insulin degludec (62 units). Patients treated with IDegLira had a 37% lower rate of hypoglycaemia versus insulin degludec (p<0.0001) whereas liraglutide was associated with less hypoglycaemia.[1]

Also during the scientific meeting, additional findings from two analyses based on the 52-week DUAL(TM) I and 26-week DUAL(TM) II trials were presented:

1) Impact of BMI on HbA1c Reduction, Hypoglycemia Rates and Insulin Requirements in Response to IDegLira in Patients With Type 2 Diabetes (Abstract #0066-OR; presented by John Buse)[2] 2) IDegLira Efficacy Across the Range of Disease Progression in Type 2 Diabetes (Abstract #0067-OR; presented by Helena Rodbard)[3]

More information on those studies is available upon request.

The most frequently occurring adverse events (greater than or equal to5%) seen at the conclusion of the DUAL(TM) I extension trial for IDegLira, insulin degludec and liraglutide were diarrhoea (10.2%, 6.8%, 16.3%); nausea (10.3%, 3.9%, 22.3%); vomiting (5%, 2.4%, 9.2%); headache (12.8%, 10.9%, 14.6%); nasopharyngitis, usually referred to as the common cold (13.9%, 12.6%, 13.3%); increased lipase (5.8%, 4.4%, 8.5%); and decreased appetite (2.7%, 0.5%, 7.3%), respectively.[4]

About the DUAL(TM) clinical programme

DUAL(TM) (DUal Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) consists of two phase 3a trials encompassing more than 2,000 people with type 2 diabetes.

DUAL(TM) I (1,663 people) - a 26-week, randomised, parallel, three-arm, open-label, multicentre, trial conducted at 271 sites across 19 countries. The trial compared the efficacy and safety of IDegLira versus insulin degludec and liraglutide alone, in insulin-naive adults with type 2 diabetes uncontrolled with metformin with or without pioglitazone. A 26-week extension phase of the main trial was conducted to generate longer-term safety and efficacy data. The topline results from the main period were reported in 2012.

DUAL(TM) II (398 people) - a 26-week, randomised, parallel, two-arm, double-blinded, multicentre, trial conducted at 75 sites across seven countries. The trial compared the efficacy and safety of IDegLira and insulin degludec once daily, both added on to metformin in adults with type 2 diabetes uncontrolled on basal insulin (20-40 units) in combination with metformin with or without sulfonylurea/glinides. Sulfonylureas and glinides were discontinued at randomisation. In this trial, the allowed maximum dose of insulin degludec in the treatment arms was 50 units so as to be able to demonstrate the contribution of the liraglutide component of IDegLira on glycaemic control. The topline results were reported in 2012.

About IDegLira

IDegLira, which is being developed for the treatment of type 2 diabetes, is a combination of insulin degludec, a once-daily basal insulin analogue with an ultralong duration of action, and liraglutide, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes. IDegLira is being investigated in the Phase 3 DUAL(TM) clinical trial programme. Novo Nordisk submitted the regulatory filing for IDegLira in the EU on 31 May 2013.

Insulin degludec has received regulatory approval and is marketed as Tresiba(R) in many countries including Argentina, Aruba, Bangladesh, Brazil, Chile, El Salvador, the EU, Iceland, India, Japan, Lebanon, Liechtenstein, Macedonia, Mexico, Norway, Russia and Switzerland. Insulin degludec is currently under review by the U.S. Food and Drug Administration

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