Efficacy and safety of liraglutide 3.0 mg and 1.8 mg in weight loss responders from overweight/obese adults with type 2 diabetes (T2D): A subgroup analysis of the SCALE Diabetes trial — ASN Events
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Efficacy and safety of liraglutide 3.0 mg and 1.8 mg in weight loss responders from overweight/obese adults with type 2 diabetes (T2D): A subgroup analysis of the SCALE Diabetes trial (#306)

Trisha O'Moore-Sullivan 1 , Ralph DeFronzo 2 , Richard Bergenstal 3 , Melanie Davies 4 , Robert Kushner 5 , Trine V Skjøth 6 , Alana Philips 7 , Ofri Mosenzon 8
  1. Mater Health Services, QLD Diabetes Centre, Brisbane, QLD, Australia
  2. Texas Diabetes Institute, San Antonio, TX, USA
  3. International Diabetes Center, Minneapolis, MN, USA
  4. Diabetes Research Centre, University of Leicester, Leicester, UK
  5. Northwestern University, Chicago, IL, USA
  6. Novo Nordisk A/S, Copenhagen, Denmark
  7. Novo Nordisk, Baulkham Hills, NSW, Australia
  8. Hadassah Hebrew University Hospital, Jerusalem, Israel

SCALE Diabetes (NCT01272232); a 56-week, randomised, double-blind, placebo-controlled trial evaluating efficacy and safety of liraglutide for weight management in overweight/obese adults with comorbid T2D. 846 individuals were randomised 2:1:1 to liraglutide 3.0 mg (n=423), 1.8 mg (n=211) or placebo (n=212) as adjunct to diet and exercise. Mean age 54.9 years, 50% male, BMI 37.1 kg/m2, HbA1c 7.9%, T2D duration 7.3 years.

This subgroup analysis compared efficacy and safety in responders (≥5% weight loss from baseline at week 56) vs. non-responders.

Mean weight loss for responders vs. non-responders was 10.3% vs. 1.6% with liraglutide 3.0 mg, 10.4% vs. 1.3% with liraglutide 1.8 mg and 9.7% vs. 0.7% with placebo. More individuals receiving liraglutide 3.0 mg (49.9%) and 1.8 mg (35.6%) vs. placebo (13.8%) were responders (p<0.0001).

Liraglutide 3.0 mg, 1.8 mg, and placebo reduced HbA1c by 1.6, 1.5, and 1.1% for responders, vs. 1.0, 1.0, and 0.2% for non-responders, respectively. SBP was reduced by 5.0, 6.2 and 5.3 mmHg in responders with liraglutide 3.0 mg, 1.8 mg and placebo, respectively; and 0.5, 1.9 and 0.5 mmHg in non-responders. Physical-function scores using IWQoL-LITE improved by 19.0, 16.4 and 15.5 with liraglutide 3.0 mg, 1.8 mg and placebo, respectively, in responders vs. 11.1, 10.4 and 7.7 in non-responders.

In responders vs. non-responders, 96% vs. 92% reported AEs with liraglutide 3.0 mg, 96% vs. 90% with liraglutide 1.8 mg and 94% vs. 85% with placebo. For serious AEs, no marked differences between responders and non-responders were observed. Most frequent AEs were gastrointestinal, seen more frequently in responders vs. non-responders for liraglutide 3.0 mg (76% vs. 55%) but not different for liraglutide 1.8 mg (58% vs. 57%) or placebo (41% vs. 39%). Rates (events/patient-year) of documented symptomatic hypoglycaemia (plasma glucose ≤3.1 mmol/L) were similar in responders vs. non-responders across all groups.

Proportionally more individuals achieved clinically-meaningful (≥5%) weight loss at 56 weeks with liraglutide 3.0 mg and 1.8 mg, vs. placebo. Responder groups lost ~10% weight at 56 weeks. Responders receiving liraglutide had greater HbA1c improvements, indicating additional benefit above that attributed to weight loss. Similar overall incidence of AEs was observed in subgroups.