New Phase 3a results demonstrate that IDegLira, an investigational once-daily single injection combination of insulin degludec and liraglutide, for the treatment of patients with type 2 diabetes, maintained its glucose-lowering effect and confirmed safety evaluations for up to one year, as presented at the 2014 American Diabetes Association Scientific Sessions.
DUAL (DUal Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) consists of two Phase 3a trials with more than 2,000 people with type 2 diabetes. DUAL I (1,663 people) is a 26-week, randomized, parallel, three-arm, open-label, multicenter trial which compared the efficacy and safety of IDegLira vs. insulin degludec and liraglutide alone, in insulin-naïve 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. Results from the main period were reported in 2012.
DUAL II (398 people) is a 26-week, randomized, parallel, two-arm, double-blinded, multicenter trial which 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 randomization. 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 glycemic control.
The DUAL I extension trial compared the efficacy and safety of IDegLira with insulin degludec and liraglutide 1.8mg alone in insulin-naïve adults with type 2 diabetes uncontrolled on metformin with or without pioglitazone. At 52 weeks, IDegLira demonstrated a statistically significant and sustained HbA1c reduction of 1.8% from baseline vs. 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% vs. 63% for insulin degludec and 57% for liraglutide. Mean fasting plasma glucose (FPG) was similar for IDegLira (103mg/dl) and insulin degludec (108mg/dl) and higher for liraglutide (132mg/dl).
At the end of the trial, the IDegLira treatment group observed a mean weight reduction of 0.4kg (0.9lbs), which was consistent with the first 26 weeks of treatment. Patient taking insulin degludec had a weight gain of 2.3kg (5.1lbs) and patients on liraglutide had a weight reduction of 3.0kg (6.6lbs). The estimated treatment difference between IDegLira and insulin degludec was -2.8kg (-6.1lbs) and the relative treatment difference between IDegLira and liraglutide was 2.7 kg(5. lbs). 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 hypoglycemia vs. insulin degludec (P<0.0001) whereas liraglutide was associated with less hypoglycaemia.
Insulin degludec is currently under review by the FDA. Victoza (liraglutide [rDNA origin]) is a human glucagon-like peptide-1 (GLP-1) analogue that was approved as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
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