• Obesity
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

• Endocrinology
• Diabetes & Metabolic Syndrome
• Obesity
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

Ralph DeFronzo, MD, University of Texas Health Science Center, San Antonio, Texas, USA, presented the results of the Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes trial [SCALE Diabetes; NCT01272232]. This large, multicenter, international trial investigated the efficacy and safety of 56 weeks of treatment with 2 doses of liraglutide, 3.0 and 1.8 mg, compared with placebo, as an adjunct to diet and exercise in inducing and maintaining weight loss in overweight or obese individuals with type 2 diabetes mellitus (T2DM). A 12-week off-medication follow-up period was designed to determine the effect of treatment cessation on safety and efficacy parameters.

Patients included in the SCALE trial had to have T2DM that was treated with diet and exercise and/or 1 to 3 oral antidiabetic drugs, body mass indexes ≥ 27 kg/m², and HbA_1c levels of 7% to 10%. Patients were to undergo lifestyle interventions, such as a hypocaloric diet and increased physical activity, throughout the duration of the trial and during the 12-week follow-up period when patients were off medication. Baseline characteristics were similar across the treatment groups (Table 1).

Weight loss was greatest during the first 4 to 6 months of treatment and then plateaued through week 56. Liraglutide provided significantly greater reductions in body weight than placebo; about half of patients lost ≥ 5% of body weight, and 20% of patients lost 10% of body weight. After 12 weeks of treatment cessation, weight regain occurred in both liraglutide groups, although mean weight loss from baseline remained significantly greater with liraglutide 3.0 mg than with placebo (−4.7% vs −2.5%, P < .001). Liraglutide resulted in statistically significant reductions in HbA_1c compared with placebo. Reductions in HbA_1c with liraglutide were steep in the initial 12 weeks and were maintained to week 56.

Liraglutide reduced fasting plasma glucose (FPG) and systolic blood pressure (SBP) within the first 2 weeks of treatment. Levels of FPG were maintained for 56 weeks but rapidly returned to baseline after treatment cessation (Table 2).

No patients developed pancreatitis during the study. Lipase and amylase activity increased early in treatment with liraglutide but remained below the upper normal limit and returned to baseline off treatment. Nausea was the most frequently reported side effect and occurred in about 15% of patients. Nausea was more common in patients treated with liraglutide. The incidence was greatest in the first 4 to 8 weeks and then gradually declined.

Liraglutide is not currently approved for weight management; however, in this study, it resulted in greater reductions in body weight in overweight or obese individuals with T2DM than placebo. In the 12 weeks after treatment stopped, patients had increases in weight, although the increases did reach the baseline weight. Benefits in FPG and SBP during treatment were also lost after treatment cessation. This study suggests that liraglutide is well tolerated and results in weight loss and improvements in FPG.

• © 2014 MD Conference Express®