Fujioka, K

Greenway, F

Jacobsen, PB

Lau, DCW

Madsbad, S

O'Neil, P

Skjoth, TV

Wilding, JPH

University of Liverpool Repository

Print this Page for Your Records Close WindowControl/Tracking Number: A-16-1493-EASDActivity: AbstractCurrent Date/Time: 3/31/2016 8:13:55 AMGreater weight loss and regression to normoglycaemia, and reduced risk of T2D, at 3 years in early weightloss responders to liraglutide 3.0 mg vs early non-respondersAuthor Block: J.P.H. Wilding1, K. Fujioka2, F. Greenway3, D.C.W. Lau4, P. O'Neil5, P.B. Jacobsen6, T.V. Skjøth6, S.Madsbad7;1University of Liverpool, Liverpool, UK, 2Scripps Clinic, La Jolla, CA, USA, 3Pennington Biomedical Research Center,Baton Rouge, LA, USA, 4University of Calgary, Calgary, AB, Canada, 5Medical University of South Carolina,Charleston, SC, USA, 6Novo Nordisk A/S, Soeborg, Denmark, 7Hvidovre Hospital, Copenhagen, Denmark.Abstract:Background and aims: The SCALE Obesity and Prediabetes trial randomised adults with prediabetes and obesity(BMI ≥30 kg/m²) or overweight with comorbidities (≥27 kg/m²; dyslipidaemia / hypertension) to liraglutide 3.0 mg(N=1505) or placebo (N=749) as adjunct to diet and exercise for 3 years. This post hoc analysis compared liraglutide3.0 mg early responders (ERs: ≥5% weight loss at week 16) and early non-responders (ENRs: <5% weight loss atweek 16), in keeping with EMA stopping-rule criteria.Materials and methods: Efficacy outcomes are estimated means in ERs (n=580) and ENRs (n=210) who completed160 weeks of treatment. Those developing T2D or regressing to normoglycaemia were analysed on the full analysisset with LOCF. Safety was based on the safety analysis set (n=886 ERs, n=416 ENRs). Placebo data are shown onlyfor proportion of ERs/ENRs.Results: Of individuals with week 16 data, for liraglutide 3.0 mg (n=1302) 68.0% were ERs and 32.0% ENRs; forplacebo (n=640), 22.3% were ERs and 77.7% ENRs. At week 160, greater mean and categorical weight loss andgreater improvements in cardiometabolic risk factors and patient-reported outcomes were observed in ERs toliraglutide 3.0 mg vs ENRs (Table). At week 160 0.5% of ERs and 3.2% of ENRs had been diagnosed with T2D;69.8% of ERs and 55.4% of ENRs had regressed to normoglycaemia while on treatment. Adverse events (AEs) werereported in 97.1% and 95.0% of ERs and ENRs, respectively; serious AEs in 17.7% and 12.7%; gastrointestinal AEsin 75.3% and 71.6%; and gallbladder disorders in 6.3% and 2.2%.Conclusion: Among individuals treated with liraglutide 3.0 mg, over 160 weeks a reduction in diagnoses of T2D andgreater regression to normoglycaemia were observed in ERs vs. ENRs while on treatment. Among those completing160 weeks of treatment, greater weight loss and improvements in cardiometabolic risk factors and patient-reportedoutcomes were observed in ERs vs. ENRs. Apart from gallbladder related events, which may relate to greater weightloss in ERs, AE rates were similar between ERs and ENRs.Oasis, The Online Abstract Submission System http://abstractsonline.com/submit/SubmitPrinterFriendlyVersion.asp?C...1 of 3 31/03/2016 14:16OASIS Technical Supportsupport@abstractsonline.com or call +1 217 398 1792European Association for the Study of Diabetes (EASD)Rheindorfer Weg 3D-40591 Düsseldorf - GermanyTel: +49-211-758 469 0 - Fax: +49-211-758 469 29Web: http://www.easd.orgE-mail: abstracts@easd.orgLeave OASIS FeedbackPowered by OASIS, The Online Abstract Submission and Invitation System SM© 1996 - 2016 Coe-Truman Technologies, Inc. All rights reserved.:Keyword (Complete):  41 Incretin based therapiesStudy information (Complete):*Human studies: Yes*Animal Studies: NoGrant Acknowledgement (Complete):Please select Yes or No: YesSupport: : Novo NordiskClinical Trial Registration Number (Complete):: Yes : NCT01272219Status: CompleteOasis, The Online Abstract Submission System http://abstractsonline.com/submit/SubmitPrinterFriendlyVersion.asp?C...2 of 3 31/03/2016 14:16Oasis, The Online Abstract Submission System http://abstractsonline.com/submit/SubmitPrinterFriendlyVersion.asp?C...3 of 3 31/03/2016 14:16

Greater weight loss and regression to normoglycaemia, and reduced risk of T2D, at 3 years in early weight loss responders to liraglutide 3.0 mg vs early non-responders

Greater weight loss and regression to normoglycaemia, and reduced risk of T2D, at 3 years in early weight loss responders to liraglutide 3.0 mg vs early non-responders

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