Oral Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2017

3-year efficacy and safety for liraglutide 3.0 mg in adults with obesity/overweight, prediabetes and baseline BMI <35 vs ≥35 kg/m² in the SCALE Obesity and Prediabetes, double-blind, placebo-controlled trial (#133)

John Prins 1 , Frank Greenway 2 , Carel Le Roux 3 , Barbara McGowan 4 , Xavier Pi-Sunyer 5 , Ana-Paula Cancino 6 , Luc van Gaal 7
  1. Mater Research Institute - UQ, South Brisbane, QLD, Australia
  2. Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA
  3. University College, Dublin, Ireland
  4. Guy's and St Thomas' NHS Foundation Trust, London, UK
  5. Columbia University, New York, NY, USA
  6. Novo Nordisk A/S, Søborg, Denmark
  7. Antwerp University Hospital, Antwerp, Belgium

The 3-year SCALE Obesity and Prediabetes trial (NCT01272219) randomized 2254 adults with prediabetes (female 76%; mean: age 48 years; BMI 39kg/m²) 2:1 to liraglutide 3.0mg or placebo (PBO) as adjunct to diet+exercise for 160 weeks (W).

This post-hoc analysis compared liraglutide efficacy and safety for adults with prediabetes and BMI < vs ≥35kg/m² at baseline (BL). Liraglutide treatment effect across BMI subgroups was evaluated by statistical testing of interaction between treatment and BMI subgroup.

BL characteristics were similar between liraglutide and PBO BMI subgroups (< vs ≥35) except weight-related characteristics (weight, BMI, waist circumference) and dyslipidaemia history (commoner for liraglutide BMI <35). At 160W, significantly greater mean and categorical weight losses (WLs) were seen with liraglutide vs PBO for BMI < and ≥35 (mean WL [%]: −6.4, −6.0 vs −1.7, −2.0; percentage achieved ≥5% WL: 51.1, 48.9 vs 19.7, 25.0; >10% WL: 25.7, 23.7 vs 8.9, 9.8; >15% WL: 8.1, 8.0 vs 2.5, 2.2) and greater improvements in glycaemic parameters and QoL endpoints; these treatment effects appeared to be independent of BL BMI (interaction p>0.05). While on treatment at 160W, more people with liraglutide vs PBO regressed to normoglycaemia, irrespective of BL BMI: 66.1, 65.8% vs 34.9, 36.9%. AE rates, and serious/severe AEs were generally comparable across BMI subgroups. Gallbladder-related AE rates were similar for liraglutide < and ≥35 (24 events [2.4 events/100 years-observation], 69 [3.1]) but higher than PBO (6 [1.3], 12 [1.2]). Rates of pancreatitis were low, similar between BMI < and ≥35 but higher with liraglutide vs PBO (2 [0.2], 8 [0.3] vs 1 [0.2], 1 [0.1]), as were breast neoplasms (2 [0.3], 8 [0.4] vs 0 for PBO).

In conclusion, 3 years’ treatment with liraglutide 3.0mg had similar effects on body weight, glycaemic control and safety in subjects with baseline BMI < and ≥35kg/m².