Diabetologie und Stoffwechsel 2015; 10 - LB7
DOI: 10.1055/s-0035-1556576

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

M Davies 1, B Bode 2, R Kushner 3, A Lewin 4, T Vang Skjøth 5, CB Jensen 5, R De Fronzo 6, J Kienhöfer 7, A Pfeiffer 8
  • 1Diabetes Research Centre, University of Leicester, Leicester, United Kingdom
  • 2Atlanta Diabetes Associates, Atlanta, United States
  • 3Northwestern University, Chicago, United States
  • 4National Research Institute, Los Angeles, United States
  • 5Novo Nordisk A/S, Søborg, Denmark
  • 6Texas Diabetes Institute, San Antonio, United States
  • 7Novo Nordisk Pharma GmbH, Mainz, Germany
  • 8Medizinische Klinik für Endokrinologie, Diabetes und Ernährungsmedizin, Charité – Universitätsmedizin Berlin, Berlin, Germany

Liraglutide at doses up to 1.8 mg in combination with OADs and/or basal insulin is approved for the treatment of T2D. The randomized, double-blind, placebo-controlled trial SCALE Diabetes (NCT01272232) investigated the efficacy and safety of liraglutide 3.0 mg, as adjunct to diet and exercise, for weight management in obese/overweight adults with T2D.

846 individuals (age 54.9 years, M/F 50:50, BMI 37.1 kg/m2 [27.0 – 67.6], HbA1c 7.9%, FPG 8.8 (1.9 SD) mmol/L [4.2 – 17.3], T2D duration 7.3 years [0.2 – 36.5], 11.5% on diet and exercise, 57.3% on metformin, and 31.2% combination therapy or SU monotherapy) were randomized (2:1:1) to liraglutide 3.0 mg, 1.8 mg, or placebo plus diet and exercise for 56 weeks.

On body weight change at week 56, liraglutide 3.0 mg (-5.9%) and 1.8 mg (-4.6%) were superior to placebo (-2.0%; p < 0.0001), and 3.0 mg was superior to 1.8 mg (p = 0.0024). Liraglutide 3.0 mg also achieved superior glycemic control (change in HbA1c, proportion reaching HbA1c ≤6.5%, and change in FPG) vs. liraglutide 1.8 mg (p = 0.0125; p = 0.0142; p = 0.0061) and placebo (p < 0.0001). 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 (65.2% of individuals) than 1.8 mg (56.2%) and placebo (39.2%).

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 T2D.

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