Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in people with prediabetes from the SCALE Obesity and Prediabetes randomised, double-blind, placebo-controlled trial   — ASN Events
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  3. Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in people with prediabetes from the SCALE Obesity and Prediabetes randomised, double-blind, placebo-controlled trial  

Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in people with prediabetes from the SCALE Obesity and Prediabetes randomised, double-blind, placebo-controlled trial   (#178)

John Prins 1 , Carel W Le Roux 2 , Arne Astrup 3 , Ken Fujioka 4 , Frank Greenway 5 , David CW Lau 6 , Luc van Gaal 7 , Rafael Violante Ortiz 8 , John PH Wilding 9 , Trine V Skjøth 10 , Linda Shapiro Manning 10 , Xavier Pi-Sunyer 11
  1. Mater Research Institute - UQ, South Brisbane, QLD, Australia
  2. University College, Dublin, Ireland
  3. University of Copenhagen, Copenhagen, Denmark
  4. Scripps Clinic, La Jolla, CA, USA
  5. Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA
  6. University of Calgary, Calgary, AB, Canada
  7. Antwerp University Hospital, Antwerp, Belgium
  8. Instituto Mexicano del Seguro Social, Ciudad Madero, México
  9. University of Liverpool, Liverpool, UK
  10. Novo Nordisk A/S, Søborg, Denmark
  11. Columbia University, New York, NY, USA

Background: This 3-year trial investigated the effect of liraglutide 3.0 mg, as an adjunct to diet+exercise, in delaying onset of T2D (primary endpoint) in adults with prediabetes and obesity (BMI ≥30 kg/m²) or overweight (≥27 kg/m²) with comorbidities.

Methods: Participants were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo plus 500 kcal/day deficit diet and 150 min/week exercise. Efficacy data are observed means, with last observation carried forward for missing values. Clinicaltrials.gov ID: NCT01272219.

Results: Of 2254 randomised individuals with prediabetes (age 47.5±11.7 years, 76.0% female, weight 107.6±21.6 kg, BMI 38.8±6.4 kg/m², mean±SD), 1128 completed 160 weeks (52.6% on liraglutide, 45.0% on placebo). At Week 160, mean weight loss (WL) was 6.1% with liraglutide vs. 1.9% with placebo (estimated treatment difference ‑4.3% [95%CI -4.9;-3.7], p<0.0001). Comparing liraglutide and placebo, 49.6% vs 23.7% of individuals achieved ≥5% WL (estimated odds ratio [OR] 3.2 [2.6;3.9]) and 24.8% vs 9.9% achieved >10% WL (OR 3.1 [2.3;4.1]), both pp<0.001; hazard ratio: 0.2). Liraglutide was generally well tolerated. Gallbladder-related events (2.9 vs 1.2/100 patient-years of observation [PYO]) and confirmed pancreatitis (0.29 vs 0.13 events/100 PYO) were low, but more frequent with liraglutide.

Conclusion: Liraglutide 3.0 mg, plus diet+exercise over 3 years was associated with greater weight loss and reduced risk of T2D compared to placebo.

Supported by Novo Nordisk.

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