Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Obesity Clinical Trial

Official title:

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272219
• Other study ID #: NN8022-1839
• Secondary ID: 2008-001049-24U1
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2011
• Last updated: December 20, 2017
• Start date: June 1, 2011
• Est. completion date: March 2, 2015

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3731
• Est. completion date: March 2, 2015
• Est. primary completion date: March 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained

• Body Mass Index (BMI) of 30.0 kg/m^2 or above

• Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension

• Stable body weight

• Preceding failed dietary effort

Exclusion Criteria:

• Known type 1 or type 2 diabetes

• Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)

• Screening calcitonin of 50 ng/L or above

• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

• Personal history of non-familial medullary thyroid carcinoma

• History of acute or chronic pancreatitis

• Obesity induced by drug treatment

• Use of approved weight lowering pharmacotherapy

• Previous surgical treatment of obesity

• History of major depressive disorder or suicide attempt

• Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Related Conditions & MeSH terms

• Body Weight
• Glucose Intolerance
• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight
• Prediabetic State

Intervention

Drug:
• liraglutide
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
• placebo
Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
• liraglutide
Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
• placebo
Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Ciudad Autónoma de Bs As
Argentina	Novo Nordisk Investigational Site	Ciudad Autónoma de BsAs
Argentina	Novo Nordisk Investigational Site	Ciudad de Buenos Aires
Argentina	Novo Nordisk Investigational Site	Mar del Plata
Australia	Novo Nordisk Investigational Site	Adelaide	South Australia
Australia	Novo Nordisk Investigational Site	Heidelberg West	Victoria
Australia	Novo Nordisk Investigational Site	University Of Sydney	New South Wales
Australia	Novo Nordisk Investigational Site	Woolloongabba	Queensland
Austria	Novo Nordisk Investigational Site	Graz
Austria	Novo Nordisk Investigational Site	Salzburg
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Belgium	Novo Nordisk Investigational Site	Boussu
Belgium	Novo Nordisk Investigational Site	Edegem
Belgium	Novo Nordisk Investigational Site	Liège
Brazil	Novo Nordisk Investigational Site	Campinas	Sao Paulo
Brazil	Novo Nordisk Investigational Site	Curitiba
Brazil	Novo Nordisk Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novo Nordisk Investigational Site	São Paulo
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Cambridge	Ontario
Canada	Novo Nordisk Investigational Site	Edmonton	Alberta
Canada	Novo Nordisk Investigational Site	Halifax	Nova Scotia
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	Novo Nordisk Investigational Site	Ottawa	Ontario
Canada	Novo Nordisk Investigational Site	Pointe Claire	Quebec
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	St. John's	Newfoundland and Labrador
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	Frederiksberg C
Denmark	Novo Nordisk Investigational Site	Hvidovre
Finland	Novo Nordisk Investigational Site	Kuopio
Finland	Novo Nordisk Investigational Site	Oulu
Finland	Novo Nordisk Investigational Site	University Of Helsinki
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Belgrade
France	Novo Nordisk Investigational Site	Antibes
France	Novo Nordisk Investigational Site	Lille
France	Novo Nordisk Investigational Site	Paris
France	Novo Nordisk Investigational Site	PARIS cedex 13
France	Novo Nordisk Investigational Site	Pierre-Bénite
France	Novo Nordisk Investigational Site	Saint Herblain
Germany	Novo Nordisk Investigational Site	Bad Nauheim
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Dresden
Germany	Novo Nordisk Investigational Site	Duisburg
Germany	Novo Nordisk Investigational Site	Freiburg
Germany	Novo Nordisk Investigational Site	Giessen
Germany	Novo Nordisk Investigational Site	Gifhorn
Germany	Novo Nordisk Investigational Site	Leipzig
Germany	Novo Nordisk Investigational Site	Mannheim
Germany	Novo Nordisk Investigational Site	Saint Ingbert
Hong Kong	Novo Nordisk Investigational Site	Shatin, New Territories
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Debrecen
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Belgaum	Karnataka
India	Novo Nordisk Investigational Site	Karnal
India	Novo Nordisk Investigational Site	Kerala
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Pune	Maharashtra
India	Novo Nordisk Investigational Site	Trichy	Tamil Nadu
Ireland	Novo Nordisk Investigational Site	Dublin
Ireland	Novo Nordisk Investigational Site	Dublin
Ireland	Novo Nordisk Investigational Site	Dublin 9
Ireland	Novo Nordisk Investigational Site	Galway
Israel	Novo Nordisk Investigational Site	Haifa
Israel	Novo Nordisk Investigational Site	Jerusalem
Israel	Novo Nordisk Investigational Site	Kfar Saba
Israel	Novo Nordisk Investigational Site	Ofakim
Israel	Novo Nordisk Investigational Site	Petah-Tikva
Israel	Novo Nordisk Investigational Site	Petah-Tikva
Israel	Novo Nordisk Investigational Site	Tel Hashomer
Israel	Novo Nordisk Investigational Site	Tel-Aviv
Italy	Novo Nordisk Investigational Site	Bologna
Italy	Novo Nordisk Investigational Site	Firenze
Italy	Novo Nordisk Investigational Site	Milano
Italy	Novo Nordisk Investigational Site	Padova
Italy	Novo Nordisk Investigational Site	Palermo
Italy	Novo Nordisk Investigational Site	Pisa
Italy	Novo Nordisk Investigational Site	Roma
Italy	Novo Nordisk Investigational Site	Siena
Mexico	Novo Nordisk Investigational Site	Durango
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Mexico City	México, D.F.
Mexico	Novo Nordisk Investigational Site	Mexico City	México, D.F.
Mexico	Novo Nordisk Investigational Site	Monterrey
Mexico	Novo Nordisk Investigational Site	Pachuca	Hidalgo
Mexico	Novo Nordisk Investigational Site	Tampico	Tamaulipas
Netherlands	Novo Nordisk Investigational Site	Almere
Netherlands	Novo Nordisk Investigational Site	Amsterdam
Netherlands	Novo Nordisk Investigational Site	Beek
Netherlands	Novo Nordisk Investigational Site	Hengelo OV
Netherlands	Novo Nordisk Investigational Site	Hilversum
Netherlands	Novo Nordisk Investigational Site	Leidschendam
Netherlands	Novo Nordisk Investigational Site	Zwijndrecht
Norway	Novo Nordisk Investigational Site	Bergen
Norway	Novo Nordisk Investigational Site	Oslo
Norway	Novo Nordisk Investigational Site	Tønsberg
Norway	Novo Nordisk Investigational Site	Trondheim
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Katowice
Poland	Novo Nordisk Investigational Site	Katowice
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Szczecin
Poland	Novo Nordisk Investigational Site	Szczecin
Poland	Novo Nordisk Investigational Site	Warszawa
Russian Federation	Novo Nordisk Investigational Site	Arkhangelsk
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Novosibirsk
Russian Federation	Novo Nordisk Investigational Site	Tumen
Serbia	Novo Nordisk Investigational Site	Belgrade
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
Spain	Novo Nordisk Investigational Site	Almería
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Santiago de Compostela
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valladolid
Switzerland	Novo Nordisk Investigational Site	Baden-Dättwil
Switzerland	Novo Nordisk Investigational Site	Bern
Switzerland	Novo Nordisk Investigational Site	Genève 14
Switzerland	Novo Nordisk Investigational Site	St. Gallen
Switzerland	Novo Nordisk Investigational Site	Zollikerberg
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
United Kingdom	Novo Nordisk Investigational Site	Coventry
United Kingdom	Novo Nordisk Investigational Site	Glasgow
United Kingdom	Novo Nordisk Investigational Site	Hull
United Kingdom	Novo Nordisk Investigational Site	Liverpool
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Luton
United Kingdom	Novo Nordisk Investigational Site	Swansea
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Arlington	Virginia
United States	Novo Nordisk Investigational Site	Athens	Georgia
United States	Novo Nordisk Investigational Site	Aurora	Illinois
United States	Novo Nordisk Investigational Site	Aurora	Colorado
United States	Novo Nordisk Investigational Site	Austin	Texas
United States	Novo Nordisk Investigational Site	Baltimore	Maryland
United States	Novo Nordisk Investigational Site	Baton Rouge	Louisiana
United States	Novo Nordisk Investigational Site	Beaver	Pennsylvania
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Boynton Beach	Florida
United States	Novo Nordisk Investigational Site	Bradenton	Florida
United States	Novo Nordisk Investigational Site	Bristol	Tennessee
United States	Novo Nordisk Investigational Site	Canal Fulton	Ohio
United States	Novo Nordisk Investigational Site	Cary	North Carolina
United States	Novo Nordisk Investigational Site	Charleston	South Carolina
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Colorado Springs	Colorado
United States	Novo Nordisk Investigational Site	Concord	California
United States	Novo Nordisk Investigational Site	Crystal River	Florida
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Daytona Beach	Florida
United States	Novo Nordisk Investigational Site	Dunwoody	Georgia
United States	Novo Nordisk Investigational Site	Elkridge	Maryland
United States	Novo Nordisk Investigational Site	Eugene	Oregon
United States	Novo Nordisk Investigational Site	Franklin	Ohio
United States	Novo Nordisk Investigational Site	Golden	Colorado
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Henrico	Virginia
United States	Novo Nordisk Investigational Site	Huntington Beach	California
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Kansas City	Missouri
United States	Novo Nordisk Investigational Site	La Jolla	California
United States	Novo Nordisk Investigational Site	Milwaukee	Wisconsin
United States	Novo Nordisk Investigational Site	New London	Connecticut
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	North Dartmouth	Massachusetts
United States	Novo Nordisk Investigational Site	Ocala	Florida
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Phoenix	Arizona
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Ponte Vedra	Florida
United States	Novo Nordisk Investigational Site	Raleigh	North Carolina
United States	Novo Nordisk Investigational Site	Renton	Washington
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	Rochester	New York
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Saint Peters	Missouri
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	Sandy Springs	Georgia
United States	Novo Nordisk Investigational Site	Santa Monica	California
United States	Novo Nordisk Investigational Site	South Miami	Florida
United States	Novo Nordisk Investigational Site	Staten Island	New York
United States	Novo Nordisk Investigational Site	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Suwanee	Georgia
United States	Novo Nordisk Investigational Site	Syracuse	New York
United States	Novo Nordisk Investigational Site	Topeka	Kansas
United States	Novo Nordisk Investigational Site	Tulsa	Oklahoma
United States	Novo Nordisk Investigational Site	Virginia Beach	Virginia
United States	Novo Nordisk Investigational Site	Wadsworth	Ohio
United States	Novo Nordisk Investigational Site	Washington	District of Columbia
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	Wenatchee	Washington
United States	Novo Nordisk Investigational Site	West Jordan	Utah
United States	Novo Nordisk Investigational Site	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  Finland,  Former Serbia and Montenegro,  France,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

References & Publications (15)

Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. — View Citation

Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6 — View Citation

Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or — View Citation

Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spr — View Citation

Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19. — View Citation

Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12 — View Citation

le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis. Obes Facts. 2017 Nov 17;10(6):531-544. doi: 10.1159/0 — View Citation

le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjøth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and we — View Citation

McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review. — View Citation

O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3 — View Citation

O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity – Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT A — View Citation

Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. — View Citation

Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Manage — View Citation

von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10. — View Citation

Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Fasting Body Weight	The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Primary	Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.	Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At Week 56
Primary	Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight	Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At 56 weeks
Primary	Proportion of Subjects With Onset of Type 2 Diabetes	Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	At 160 weeks
Secondary	Change From Baseline in Waist Circumference (cm)	The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Secondary	Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)	The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Secondary	Pre-diabetes Status After 56 Weeks of Treatment	Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).	Week 0, Week 56
Secondary	Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment	Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Secondary	Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)	The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Secondary	Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)	Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	At 160 weeks
Secondary	Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)	The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).	Week 56, Week 68
Secondary	Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)	The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).	Week 0, Week 68

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