SFEEU2017 Obesity Update Poster Presentations (14 abstracts)
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
Barbara McGowan 1 , Carel Le Roux 2 , Arne Astrup 3 , Ken Fujioka 4 , Frank Greenway 5 , David Lau 6 , Luc Van Gaal 7 , Rafael Violante Ortiz 8 , John Wilding 9 , Trine Skjoth 10 & Xavier Pi-Sunyer 11
1Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 2University College Dublin, Dublin, Ireland; 3University of Copenhagen, Frederiksberg, Denmark; 4Scripps Clinic, La Jolla, CA, USA; 5Pennington Biomedical Research Center, Baton Rouge, LA, USA; 6University of Calgary, Calgary, AB, Canada; 7Antwerp University Hospital, Antwerp, Belgium; 8Instituto Mexicano del Seguro Social, Cuidad Madero, Mexico; 9University of Liverpool, Liverpool, UK; 10Novo Nordisk, Soeborg, Denmark; 11Columbia University, New York, NY, USA.
Background: The 3-year part of this 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±S.D.), 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 P<0.0001. Based on the Kaplan-Meier plot of cumulative probability of a diagnosis of diabetes that takes censoring into account, 3% of patients in the liraglutide group vs 11% in the placebo group were diagnosed with diabetes by week 160 while on treatment. With continued treatment over 160 weeks, the estimated time to onset of diabetes was 2.7 times longer with liraglutide than with placebo (95% CI, [1.9;3.9], P<0.001), corresponding to a hazard ratio of 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 for 3 years, plus diet+exercise, was associated with lower risk of T2D and greater weight loss compared with placebo.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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