Among overweight and obese patients with type 2 diabetes, daily injection of the diabetes drug liraglutide with a modified insulin pen device, in addition to diet and exercise, resulted in greater weight loss over 56 weeks compared with placebo, according to a study in the August 18 issue of JAMA.
Obesity is a chronic disease and a significant global health challenge. Weight loss is recommended for patients with type 2 diabetes. Moderate weight loss (5 percent-10 percent) can improve glycemic control and other cardiometabolic risk factors and disorders. Weight loss is especially challenging for individuals with type 2 diabetes, who often experience a reduced response to weight-management pharmacotherapies compared with individuals without diabetes. Liraglutide is a medication approved for the treatment of type 2 diabetes (administered once daily at doses of 1.2 mg and 1.8 mg). Weight loss has also been observed with liraglutide at these doses, according to background information in the article.
Melanie J. Davies, M.D., of the University of Leicester, United Kingdom, and colleagues randomly assigned 846 overweight or obese study participants (age 18 years or older) with type 2 diabetes to once-daily injections of liraglutide (3.0 mg) (n = 423), liraglutide (1.8 mg) (n = 211), or placebo (n = 212) for 56 weeks. A 12-week "off-drug" follow-up period was included to assess treatment-cessation effects (total study length, 68 weeks). The study was conducted at 126 sites in 9 countries between June 2011 and January 2013. Participants were also instructed to follow a reduced-calorie diet and increase physical activity for weight management.
Average weight loss was 6.0 percent (14.1 lbs.) with liraglutide (3.0-mg dose), 4.7 percent (11 lbs.) with liraglutide (1.8-mg dose), and 2.0 percent (4.8 lbs.) with placebo. Weight loss of 5 percent or greater occurred in 54.3 percent with liraglutide (3.0 mg) and 40.4 percent with liraglutide (1.8 mg) vs 21.4 percent with placebo. Weight loss greater than 10 percent occurred in 25.2 percent with liraglutide (3.0 mg) and 15.9 percent with liraglutide (1.8 mg) vs 6.7 percent with placebo. More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. Pancreatitis was not reported.
"To our knowledge, this is the first study specifically designed to investigate the efficacy of liraglutide for weight management in patients with type 2 diabetes and also the first study to investigate liraglutide at the higher 3.0-mg dose in a population with type 2 diabetes," the authors write. "In the present trial, liraglutide (3.0 mg), as an adjunct to a reduced-calorie diet and increased physical activity, was effective and generally well tolerated and was significantly better than placebo on all 3 co-primary weight-related end points."
"Further studies are needed to evaluate longer-term efficacy and safety."
(doi:10.1001/jama.2015.9676; Available pre-embargo to the media at http://media.
Editor's Note: This study was funded by Novo Nordisk. Liraglutide is a Novo Nordisk A/S proprietary compound. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.