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SCALE trial

SCALE trial: Liraglutide assists diabetics in losing weight

Credit: Mr Hyde/Czech Wikipedia
Liraglutide is a medication approved for the treatment of type 2 diabetes (administered once daily at doses of 1.2mg and 1.8mg)
Further studies are needed to evaluate longer-term efficacy and safety

Overweight and obese patients with type 2 diabetes who received a daily injection of the diabetes drug liraglutide with a modified insulin pen device, in addition to diet and exercise, lost more weight over 56 weeks compared with placebo, according to a study ‘Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes - The SCALE Diabetes Randomized Clinical Trial’, published in JAMA. Liraglutide is a medication approved for the treatment of type 2 diabetes (administered once daily at doses of 1.2mg and 1.8mg).

"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 (3.0mg), 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 three co-primary weight-related end points.”

Dr Melanie J Davies from the University of Leicester, UK, 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 (3.0mg) (n=423), liraglutide (1.8mg) (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 nine countries between June 2011 and January 2013. Participants were also instructed to follow a reduced-calorie diet and increase physical activity for weight management.

Baseline weight was 105.7 kg with liraglutide (3.0mg dose), 105.8kg with liraglutide (1.8mg dose), and 106.5kg with placebo. Weight loss was 6.0% (6.4kg) with liraglutide (3.0mg dose), 4.7% (5.0kg) with liraglutide (1.8mg dose), and 2.0% (2.2kg) with placebo (estimated difference for liraglutide [3.0mg] vs placebo, −4.00% [95% CI, −5.10% to −2.90%]; liraglutide [1.8 mg] vs placebo, −2.71% [95% CI, −4.00% to −1.42%]; p<0.001 for both). Weight loss of 5% or greater occurred in 54.3% with liraglutide (3.0mg) and 40.4% with liraglutide (1.8mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8mg] vs placebo, 19.0% [95% CI, 9.1% to 28.8%]; p<0.001 for both). Weight loss greater than 10% occurred in 25.2% with liraglutide (3.0mg) and 15.9% with liraglutide (1.8mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], p<0.001; for liraglutide [1.8 mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], p=.006). More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8mg) and placebo.

“Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0mg) daily, compared with placebo, resulted in weight loss over 56 weeks,” the authors concluded. “Further studies are needed to evaluate longer-term efficacy and safety.”

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