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

Characteristics of individuals developing type 2 diabetes in the SCALE Obesity and Prediabetes randomised, double-blind, liraglutide vs placebo trial (#246)

Samantha Hocking 1 , David CW Lau 2 , Matthias Matthias Blüher 3 , Luc van Gaal 4 , Domenica M Rubino 5 , German Guerrero 6 , Linda Shapiro Manning 7 , John PH Wilding 8
  1. Boden Initiative, Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia
  2. Medicine, Biochemistry and Molecular Biology, University of Calgary, Calgary, AB, Canada
  3. University of Leipzig, Leipzig, Germany
  4. Antwerp University Hospital, Antwerp, Belgium
  5. Washington Center for Weight Management and Research, Arlington, VA, USA
  6. Novo Nordisk Inc, Plainsboro, NJ, USA
  7. Novo Nordisk A/S, Soeborg, Denmark
  8. University of Liverpool, Liverpool, UK

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

Methods: Individuals were randomised 2:1 to once-daily s.c. liraglutide 3.0 mg (n=1505) or placebo (n=749), with a 500-kcal/day deficit diet and 150-min/week exercise. Efficacy data are observed means, with LOCF. Clinicaltrials.gov NCT01272219.

Results: Compared to the entire randomised population, at baseline, individuals who developed T2D by week 160 (liraglutide 3.0mg, n=26; placebo, n=46) were on average older (population developing T2D by week 160): liraglutide 48.4±8.3 years; placebo 49.3±13.2 vs entire population: liraglutide 47.5±11.7; placebo 47.3±11.8), had more dyslipidaemia (14 patients [54%]; 21 patients [46%] vs 499 patients [33%]; 249 patients [33%]) and hypertension (19 patients [73%]; 18 patients [39%] vs 635 patients [42%]; 312 patients [42%]), had higher baseline HbA1c (mean[SD]) (6.1±0.4%; 5.9±0.4%; vs 5.8±0.3%; 5.7±0.3%) and FPG (mean [SD]) (6.0±0.6 mmol/L; 5.9±0.6 mmol/L; vs 5.5±0.6 mmol/L; 5.5±0.5 mmol/L) and a higher BMI (40.2±8.6; 40.4±7.0; vs 38.8±6.4; 39.0±6.3 kg/m2). Time to onset of T2D over 3 years was 2.7-fold longer with liraglutide 3.0 mg compared with placebo (95%CI 1.9;3.9; p<0.0001), corresponding to a hazard-ratio of 0.2. Mean weight loss at 3 years for the entire study population was 6.1% with liraglutide 3.0 mg vs 1.9% with placebo (estimated difference ‑4.3% [95%CI -4.9;-3.7], p<0.0001). Most individuals who developed T2D (>90% in both groups) lost less body-weight than the treatment group mean. In those with T2D, one hypoglycaemic event was reported with liraglutide 3.0 mg vs five with placebo, none severe. Liraglutide 3.0 mg was generally well tolerated.

Conclusion: Liraglutide 3.0 mg, as an adjunct to diet+exercise, delayed the time to onset and reduced the risk of developing T2D vs placebo over 3 years.

Supported by Novo Nordisk.