Liraglutide 3.0 mg for weight management in obese/overweight adults with type 2 diabetes: Results from the SCALE Diabetes 56-week randomised, double-blind, placebo-controlled trial — ASN Events

Liraglutide 3.0 mg for weight management in obese/overweight adults with type 2 diabetes: Results from the SCALE Diabetes 56-week randomised, double-blind, placebo-controlled trial (#9)

John Prins 1 , Melanie Davies 2 , Bruce Bode 3 , Robert Kushner 4 , Andrew Lewin 5 , Trine V Skjøth 6 , Alana Philips 7 , Ralph DeFronzo 8
  1. Mater Medical Research Institute, South Brisbane, QLD, Australia
  2. Diabetes Research Centre, University of Leicester, Leicester, UK
  3. Atlanta Diabetes Associates, Atlanta, GA, USA
  4. Northwestern University, Chicago, IL, USA
  5. (Retired) National Research Institute, Los Angeles, CA, USA
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Novo Nordisk Pharmaceuticals, Sydney, NSW, Australia
  8. Texas Diabetes Institute, San Antonio, TX, USA

Liraglutide at doses up to 1.8 mg is approved for the treatment of type 2 diabetes (T2D). This study investigated the efficacy and safety of liraglutide 3.0 mg, as adjunct to diet and exercise, for weight management in obese/overweight adults with comorbid T2D.

846 individuals (mean age 54.9 years, male/female 50:50, body mass index 37.1 kg/m2 [27.0-67.6], HbA1c 7.9%, fasting plasma glucose [FPG] 8.8 mmol/L, T2D duration 7.3 years [0.2-36.5], 11.5% on diet and exercise, 57.3% on metformin, and 31.2% on SU monotherapy or combination oral antidiabetic medications) were randomised (2:1:1) to liraglutide 3.0 mg, 1.8 mg, or placebo plus diet (500 kcal/day deficit) and exercise for 56 weeks. Clinicaltrials.gov ID: NCT01272232.

Liraglutide 3.0 mg and 1.8 mg were superior to placebo, and 3.0 mg was superior to 1.8 mg on mean and categorical weight loss at week 56 (Table). Liraglutide 3.0 mg also achieved superior glycaemic control (change in HbA1c, proportion reaching HbA1c ≤6.5%, and change in FPG) vs. liraglutide 1.8 mg and placebo (Table). The safety profile with liraglutide 3.0 mg was similar to that of liraglutide 1.8 mg with no differences in safety/tolerability between the 2 doses, except that gastrointestinal disorders were more frequent with 3.0 mg (65% of individuals) than 1.8 mg (56%) and placebo (39%).

Liraglutide 3.0 mg, as adjunct to diet and exercise, was efficacious and well-tolerated for weight management over 56 weeks in obese/overweight individuals with comorbid T2D.

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