Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2016

Early weight loss responders to liraglutide 3.0 mg had greater weight loss, regression to normoglycaemia, and reduced T2D development at 3 years vs early non-responders: SCALE Obesity and Prediabetes (#245)

Samantha Hocking 1 , David CW Lau 2 , Ken Fujioka 3 , Frank Greenway 4 , Patrick O'Neil 5 , John PH Wilding 6 , Peter B Jacobsen 7 , Trine V Skjøth 7 , Sten Madsbad 8
  1. The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, University of Sydney, Sydney, NSW, Australia
  2. Medicine, Biochemistry and Molecular Biology, University of Calgary, Calgary, AB, Canada
  3. Endocrinology, Scripps Clinic, La Jolla, CA, USA
  4. Pennington Biomedical Research Center, Baton Rouge, LA, USA
  5. Medical University of South Carolina, Charleston, SC, USA
  6. University of Liverpool, Liverpool, UK
  7. Novo Nordisk A/S, Soeborg, Denmark
  8. Hvidovre Hospital, Hvidovre, Denmark

Background: The SCALE Obesity and Prediabetes (NCT01272219) trial randomised adults with prediabetes and obesity (BMI ≥30 kg/m²) or overweight with comorbidities (≥27 kg/m²; dyslipidaemia/hypertension) to liraglutide 3.0 mg (N=1505) or placebo (N=749) as adjunct to diet and exercise for 3 years.

Methods: This post-hoc analysis compared liraglutide 3.0 mg early responders (ERs; ≥5% weight loss [WL] at Week [W] 16) and early non-responders (ENRs; <5% WL at W16), in keeping with EMA and Australian stopping-rule criteria. Efficacy outcomes are estimated means in ERs (n=580) and ENRs (n=210) who completed 160 weeks’ treatment. Development of T2D/regression to normoglycaemia were analysed using the full analysis set with LOCF. Safety was analysed using the safety analysis set. Placebo data are shown only for proportion of ERs/ENRs.

Results: Of those with W16 data, for liraglutide 3.0 mg (n=1302) 68.0% were ERs and 32.0% ENRs; for placebo (n=640), 22.3% were ERs and 77.7% ENRs. At W160, greater WL (–8.6% and –9.1 kg change in ER body-weight versus –2.9% and –3.1 kg for ENRs), reduced proportions of subjects developing T2D (0.5% ERs, 3.2% ENRs) and greater regression to normoglycaemia (69.8% in ERs, 55.4% in ENRs) were observed in ERs to liraglutide 3.0 mg vs ENRs. ERs showed greater clinical improvements (FPG, HbA1c, SBP levels) and patient-reported improvements compared with ENRs (SF-36 score +3.68 vs +1.81 and IWQOL-Lite score +13.40 vs +9.53 for ERs and ENRs, respectively. Increase in score=improvement). Adverse events (AEs) and GI AEs were similar between groups (87.1% and 75.3% for ERs; 95% and 71.6% for ENRs) while serious AEs and gallbladder disorders were more frequent in ERs (17.7% and 6.3% vs 12.7% and 2.2% for ENRs).

Conclusions: Among those treated with liraglutide 3.0 mg for 160 weeks, greater benefits were seen in ERs vs ENRs; overall AE rates were similar.

Supported by Novo Nordisk.