Diabetologie und Stoffwechsel 2017; 12(S 01): S1-S84
DOI: 10.1055/s-0037-1601675
Poster: *Poster + Kurzpräsentation
Adipositas
Georg Thieme Verlag KG Stuttgart · New York

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

M Blüher
1   Department of Medicine University of Leipzig, Leipzig, Germany
,
F Greenway
2   Pennington Biomedical Research Center, Baton Rouge, United States
,
CW Le Rouge
3   University College, Dublin, Ireland
,
B McGowan
4   Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom
,
X Pi-Sunyer
5   Columbia University, New York, United States
,
AP Cancino
6   Novo Nordisk A/S, Søborg, Denmark
,
R Christensen
6   Novo Nordisk A/S, Søborg, Denmark
,
J Kienhöfer
7   Novo Nordisk Pharma GmbH, Mainz, Germany
,
L Van Gaal
8   Antwerp University Hospital, Antwerp, Belgium
› Author Affiliations
Further Information

Publication History

Publication Date:
05 May 2017 (online)

Also available at
 

Background:

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

Methods:

Post hoc analysis of the SCALE Obesity and Prediabetes trial to compare efficacy and safety of liraglutide 3.0 mg for adults with prediabetes across baseline (BL) BMI subgroups < 35 vs. ≥35 kg/m2. Treatment effect of liraglutide across BMI subgroups was evaluated by statistical testing of interaction between treatment and BMI subgroup.

Results:

At 160 weeks, significantly greater mean weight losses in BMI

< 35 (-6.4% vs. -1.7%) and ≥35 kg/m2 (-6.0% vs. -2.0%), and categorical weight losses (WL) in both BMI subgroups were seen with liraglutide vs. PBO as well as greater improvements in glycemic parameters (HbA1c, FPG) and quality of life endpoints; these treatment effects appeared to be independent of BL BMI (interaction p > 0.05). While on treatment at 160 W, more people with liraglutide vs. PBO regressed to normoglycemia, irrespective of BL BMI rates for adverse events (AEs), and serious/severe AEs were generally comparable across BMI subgroups, rates of Gallbladder-related AEs were similar for liraglutide < 35 vs. ≥35, but numerically higher than PBO.

Conclusions:

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