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Novo Nordisk announced headline clinical results from a phase 3 clinical study comparing the effects of liraglutide, a once-daily human GLP-1 analogue, with exenatide, a twice-daily GLP-1 analogue.
The 26-week study, which is the first study to provide a direct comparison between the two GLP-1 analogues, included 464 people with type 2 diabetes who were randomized to treatment with either liraglutide once daily or exenatide twice daily, as add-on to their existing treatment consisting of metformin, sulfonylurea, or a combination of both.
The average HbA1c level at the beginning of the study was slightly above 8% and the primary endpoint was the change in HbA1c. Patients treated with liraglutide achieved a reduction in HbA1c of more than 1.1 percentage points, compared to a reduction in HbA1c of less than 0.8 percentage points in the exenatide group, a difference which was statistically significant. Liraglutide treatment led to statistically significantly more patients achieving both the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) HbA1c targets of <7% and <= 6.5%, respectively.
Specifically, close to 55% of patients in the liraglutide group reached the ADA target, compared to close to 45% in the exenatide group. Likewise, around 35% of patients treated with liraglutide achieved the AACE target, compared to around 20% for patients treated with exenatide.
The patients’ average weight at the beginning of the study was between 90 and 95 kg. Both patients treated with liraglutide and patients treated with exenatide lost on average around 3 kg during the course of the study, with a trend towards more weight loss in the liraglutide group. Among patients previously treated with metformin alone, this difference was 1 kg in favour of liraglutide (not statistically significant).
The most frequently reported adverse event for both liraglutide and exenatide was nausea at a level of around 25% (percent of all study participants reporting nausea at least once). In the liraglutide group, the percentage of patients reporting nausea in each week fell to low single-digit numbers after 8-10 weeks, similar to the level observed in a background population. In the exenatide group, the level after 8-10 weeks of treatment remained at the level of 10%.
As expected, the overall rate of hypoglycemia in the study was low. The rate of minor hypoglycemia was statistically significantly lower in the liraglutide group, compared to the exenatide group.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are very encouraged by the fact that the study showed that once-daily liraglutide leads to statistically significantly better blood glucose control than twice-daily exenatide. In addition, liraglutide treatment leads to weight loss and is associated with a very low risk of hypoglycemia."
Presented at the American Diabetes Association’s 68th Scientific Sessions
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