Year:
2009
Abstract Number:
1729-P
Liraglutide, a Once-Daily Human GLP-1 Analog, Reverses Indices of Prediabetes in Obese Subjects: A Randomized Placebo-Controlled 20-Week Trial Liraglutide, a human GLP-1 an Liraglutide, a human GLP-1 analog, reduces HbA1c by 1.0–1.5% and weight by 2–3 kg with doses up to 1.8 mg in patients with type 2 diabetes. This double-blind, placebo-controlled trial with open-label orlistat comparator investigated the effect of liraglutide on body weight (primary outcome; reported previously) and metabolic control, including impact on prediabetes, in obese non-diabetic subjects. We report results from a post hoc analysis of subjects with prediabetes.
Subjects (18–65 years, BMI 30–40 kg/m2), with (n=176) and without (n=364) prediabetes based on 2003 ADA guidelines, were randomized equally to 1 of 4 liraglutide doses (1.2, 1.8, 2.4 or 3.0 mg once daily s.c.), placebo s.c. or orlistat (120 mg 3× daily). All subjects received advice and support for a 500 kcal deficit diet and increased physical activity.
In the intention-to-treat population (561 of 564 randomized), the estimated mean placebo-subtracted weight loss ranged from 2.1 kg [95% CI -3.6; -0.6] (liraglutide 1.2 mg) to 4.4 kg [-6.0; -2.9] (liraglutide 3.0 mg). Prediabetes incidence was reduced by about 90% with liraglutide 1.8–3.0 mg (Table). Between 0 and 6% of liraglutide-treated subjects with normal glucose tolerance at baseline developed prediabetes. Liraglutide-treated subjects had significantly improved odds of having normal glucose tolerance at Week 20 compared to placebo/orlistat (estimated odds between 4 and 38 compared to 1.5 for placebo/orlistat; p<0.01). Compared to placebo, more nausea and vomiting events of mild to moderate intensity occurred with liraglutide, mostly within the first 4–6 weeks.
Liraglutide 1.2–3.0 mg once daily prevented the development of prediabetes and reversed existing prediabetes over 20 weeks in the majority of obese subjects.
www.clinicaltrials.gov ID NCT00422058 NICK FINER, MAZIN AL HAKIM, ARNE ASTRUP, ANGELA HARPER, MIKE LEAN, LEO NISKANEN, MADS F. RASMUSSEN, AILA RISSANEN, STEPHAN RÖSSNER, LUC VAN GAAL 1729-P Cambridge, Great Britain, Almere, The Netherlands, Frederiksberg, Denmark, Bagsvaerd, Denmark, Glasgow, Great Britain, Kuopio, Finland, Helsinki, Finland, Huddinge, Sweden, Antwerp, Belgium Obesity - Human
Subjects (18–65 years, BMI 30–40 kg/m2), with (n=176) and without (n=364) prediabetes based on 2003 ADA guidelines, were randomized equally to 1 of 4 liraglutide doses (1.2, 1.8, 2.4 or 3.0 mg once daily s.c.), placebo s.c. or orlistat (120 mg 3× daily). All subjects received advice and support for a 500 kcal deficit diet and increased physical activity.
In the intention-to-treat population (561 of 564 randomized), the estimated mean placebo-subtracted weight loss ranged from 2.1 kg [95% CI -3.6; -0.6] (liraglutide 1.2 mg) to 4.4 kg [-6.0; -2.9] (liraglutide 3.0 mg). Prediabetes incidence was reduced by about 90% with liraglutide 1.8–3.0 mg (Table). Between 0 and 6% of liraglutide-treated subjects with normal glucose tolerance at baseline developed prediabetes. Liraglutide-treated subjects had significantly improved odds of having normal glucose tolerance at Week 20 compared to placebo/orlistat (estimated odds between 4 and 38 compared to 1.5 for placebo/orlistat; p<0.01). Compared to placebo, more nausea and vomiting events of mild to moderate intensity occurred with liraglutide, mostly within the first 4–6 weeks.
Liraglutide 1.2–3.0 mg once daily prevented the development of prediabetes and reversed existing prediabetes over 20 weeks in the majority of obese subjects.
| Change Baseline to Week 20 | Liraglutide 1.2mg | Liraglutide 1.8mg | Liraglutide 2.4mg | Liraglutide 3.0mg | Placebo | Orlistat |
| Prediabetes¹ to normal² status | 18/26 (69%) | 26/27 (96%) | 23/26 (88%) | 24/25 (96%) | 13/28 (46%) | 9/22 (41%) |
| Normal to prediabetes | 3/51 (6%) | 0/44 (0%) | 1/46 (2%) | 2/53 (4%) | 11/48 (23%) | 10/53 (19%) |
Congress:
69th Scientific Sessions (2009)
Category:
Obesity - Human