Liraglutide Provides Better Glucose Control Than Insulin Glargine In Phase 3 Study

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Novo Nordisk announced clinical results from the first of five phase 3 studies with liraglutide -- the once-daily human GLP-1 analog.

The 26-week study is part of the LEAD (Liraglutide Effect and Action in Diabetes) program and included 581 patients with type 2 diabetes inadequately controlled by two of the most widely used oral anti-diabetic drugs: metformin and a sulfonylurea (glimepiride). All patients in the study continued the two oral drugs and were randomized to add one daily injection of liraglutide, placebo or insulin glargine.

The average HbA1c level at the beginning of the study was between 8.0% and 8.5% and at the end of the study, more than 50% of patients in the liraglutide group had reached the American Diabetes Association goal of HbA1c less than 7%. Furthermore, more than 35% achieved the American Association of Clinical Endocrinologists HbA1c target of less than or equal to 6.5%. The HbA1c reduction achieved in the liraglutide group was more than 0.2 percentage points better than in the insulin glargine group, a difference which is statistically significant.

The average weight of the patients at the beginning of the study was approximately 85 kg. At the end of the study, the difference in body weight between the liraglutide and insulin glargine treatment groups was on average 3.5 kg, statistically significant in favor of liraglutide.

Liraglutide in combination with metformin and glimepiride was well tolerated. The most frequently reported adverse event in the liraglutide arm was nausea at an absolute level of between 10 and 15%. As expected, the combination of a GLP-1 analogue with a sulfonylurea leads to some of the patients experiencing hypoglycemia. The overall hypoglycemia event rate in the liraglutide and insulin glargine groups was not significantly different.

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Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are very pleased with these first results from the liraglutide phase 3 program, showing that liraglutide provides improved glucose control compared to insulin glargine while, at the same time, leading to significant weight loss."

Novo Nordisk expects to announce headline results from the remaining four LEAD studies during the second half of 2007 and the first quarter of 2008. Detailed results from the full LEAD program are expected to be published in peer reviewed journals and communicated at future scientific meetings.

The results of the phase 3 trial do not change Novo Nordisk's expectations for the company's financial results for 2007, which were provided on 2 May in connection with the release of the financial results for the first three months of 2007.

Liraglutide is a once-daily human analogue of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1). The compound is being developed by Novo Nordisk for the treatment of type 2 diabetes, and is currently in phase 3 development. Liraglutide works by stimulating the release of insulin only when glucose levels become too high. In contrast to most other anti-diabetic treatments liraglutide also leads to weight loss instead of weight increase.

The LEAD program (Liraglutide Effect and Action in Diabetes) is comprised of five randomized, controlled, double-blind studies conducted in more than 40 countries. The program includes around 3,800 patients with type 2 diabetes whose blood glucose is inadequately controlled.

HbA1c is an abbreviation for glycated haemoglobin HbA1c. The level of HbA1c reflects the average blood glucose level over the past 2-3 months and a decrease is therefore a measure of treatment effect. The higher the blood glucose the more glucose binds to haemoglobin (glycation).

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