Headline results from a 56-week, double-blind, Phase IIIa trial investigating the potential of Novo Nordisk's liraglutide to induce and maintain weight loss in overweight or obese people with Type II diabetes indicated that all three co-primary endpoints have been met.
This is the second Phase IIIa trial to be completed as part of SCALE (Satiety and Clinical Adiposity â Liraglutide Evidence in Non-diabetic and Diabetic people), the clinical development programme for liraglutide 3mg as an obesity treatment. In the trial, 846 overweight or obese people with Type II diabetes were randomised 2:1:1 to treatment with liraglutide 3mg, liraglutide 1.8mg or placebo. After 56 weeks, treatment was discontinued and the subjects were followed during a 12-week observational period.
From a mean baseline weight of approximately 106kg and a body mass index of 37, the weight loss for people treated with liraglutide 3mg and liraglutide 1.8mg after 56 weeks was 6 and 5 per cent, respectively, compared with a 2 per cent weight loss for people treated with placebo. The proportion of people achieving a weight loss of at least 5 or 10 per cent was, respectively, 50 and 22 per cent for liraglutide 3mg, 35 and 13 per cent for liraglutide 1.8mg, and 13 and 4 per cent for placebo treatment. All differences for both doses of liraglutide were statistically significantly different from placebo and the trial met all three co-primary endpoints. During the 12-week follow-up period after treatment discontinuation, people in both liraglutide treatment groups experienced a moderate weight regain.
Starting from a baseline HbA1c of 8.0 per cent, approximately 69, 67 and 27 per cent of people treated with liraglutide 3mg, liraglutide 1.8mg and placebo, respectively, achieved the HbA1c treatment target of 7 per cent recommended by the American Diabetes Association and the European Association for the Study of Diabetes. In the trial, the rate of hypoglycaemia was comparable with that observed in previous trials with liraglutide. In the trial, liraglutide was generally well tolerated and the 56-week completion rate was 77, 78 and 66 per cent for liraglutide 3mg, liraglutide 1.8mg and placebo, respectively. Withdrawals due to adverse events (AEs) were below 10 per cent in all treatment groups. In line with previous liraglutide trials, the most common AEs were related to the gastrointestinal system and diminished over time. No other apparent differences between the treatment groups were observed with respect to AEs and standard safety parameters.
Novo Nordisk expects to complete the two remaining Phase IIIa trials in the SCALE programme by mid-2013.
Liraglutide, a once daily GLP-1 analogue, is not an approved treatment at the 3mg dose. Liraglutide is currently approved and marketed at lower doses (1.2 and 1.8mg once daily, as well as 0.9mg in Japan) for Type II diabetes only, under the brandname Victoza.