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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272219
First received: January 6, 2011
Last updated: November 7, 2016
Last verified: November 2016
  Purpose

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).


Condition Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Drug: liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change From Baseline in Fasting Body Weight [ Time Frame: Week 0, Week 56 ]
    The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).

  • Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. [ Time Frame: At Week 56 ]
    Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

  • Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight [ Time Frame: At 56 weeks ]
    Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

  • Proportion of Subjects With Onset of Type 2 Diabetes [ Time Frame: At 160 weeks ]
    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).


Secondary Outcome Measures:
  • Change From Baseline in Waist Circumference (cm) [ Time Frame: Week 0, Week 56 ]
    The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).

  • Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ]
    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).

  • Pre-diabetes Status After 56 Weeks of Treatment [ Time Frame: Week 0, Week 56 ]
    Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).

  • Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment [ Time Frame: Week 0, week 160 ]
    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).

  • Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ]
    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).

  • 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) [ Time Frame: At 160 weeks ]
    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).

  • Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) [ Time Frame: Week 56, Week 68 ]
    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).

  • Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) [ Time Frame: Week 0, Week 68 ]
    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).


Enrollment: 3731
Study Start Date: June 2011
Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) 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).
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) Drug: 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).
Placebo Comparator: Liraglutide Placebo, no Pre-diabetes Drug: 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).
Experimental: Liraglutide 3.0mg, Pre-diabetes Drug: liraglutide
Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Placebo Comparator: Liraglutide Placebo, Pre-diabetes Drug: placebo
Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272219

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Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35205-4731
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85027
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
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Concord, California, United States, 94520
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Huntington Beach, California, United States, 92646
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La Jolla, California, United States, 92037
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San Diego, California, United States, 92103-4140
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San Diego, California, United States, 92108
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Santa Monica, California, United States, 90404
United States, Colorado
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Aurora, Colorado, United States, 80045
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Colorado Springs, Colorado, United States, 80904
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Golden, Colorado, United States, 80401
United States, Connecticut
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New London, Connecticut, United States, 06320
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Waterbury, Connecticut, United States, 06708
United States, District of Columbia
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Washington, District of Columbia, United States, 20036-5847
United States, Florida
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Boynton Beach, Florida, United States, 33437
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Bradenton, Florida, United States, 34201
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Crystal River, Florida, United States, 34429
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Daytona Beach, Florida, United States, 32117
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32216
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Ocala, Florida, United States, 34471
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Ponte Vedra, Florida, United States, 32081
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South Miami, Florida, United States, 33143
United States, Georgia
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Athens, Georgia, United States, 30606
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Dunwoody, Georgia, United States, 30338
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Sandy Springs, Georgia, United States, 30328
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Suwanee, Georgia, United States, 30024
United States, Illinois
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Aurora, Illinois, United States, 60504
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808-4124
United States, Maryland
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Baltimore, Maryland, United States, 21209
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Elkridge, Maryland, United States, 21075-6437
United States, Massachusetts
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North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
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Kansas City, Missouri, United States, 64111
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St. Louis, Missouri, United States, 63104
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St. Louis, Missouri, United States, 63141
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St. Peters, Missouri, United States, 63376
United States, New York
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New York, New York, United States, 10025
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Rochester, New York, United States, 14609
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Staten Island, New York, United States, 10301
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Syracuse, New York, United States, 13210
United States, North Carolina
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Cary, North Carolina, United States, 27518-7414
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Raleigh, North Carolina, United States, 27612
United States, Ohio
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Canal Fulton, Ohio, United States, 44614
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Cincinnati, Ohio, United States, 45219
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Franklin, Ohio, United States, 45005
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Wadsworth, Ohio, United States, 44281-9236
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Beaver, Pennsylvania, United States, 15009
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15206
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West Reading, Pennsylvania, United States, 19611
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Greer, South Carolina, United States, 29651
United States, Tennessee
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Bristol, Tennessee, United States, 37620-7352
United States, Texas
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75234
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Dallas, Texas, United States, 75251
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Dallas, Texas, United States, 75390-8858
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San Antonio, Texas, United States, 78229-4801
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Sugar Land, Texas, United States, 77479
United States, Utah
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Salt Lake City, Utah, United States, 84107
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West Jordan, Utah, United States, 84088-8871
United States, Virginia
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Arlington, Virginia, United States, 22206
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Henrico, Virginia, United States, 23233
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Richmond, Virginia, United States, 23294
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Virginia Beach, Virginia, United States, 23454
United States, Washington
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Renton, Washington, United States, 98057
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Wenatchee, Washington, United States, 98801-2028
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53209
Argentina
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Ciudad Autónoma de Bs As, Argentina, C1426ABP
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Ciudad Autónoma de BsAs, Argentina, C1406FWY
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Ciudad de Buenos Aires, Argentina, C1405CWB
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Mar del Plata, Argentina, B7600FZN
Australia, New South Wales
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University of Sydney, New South Wales, Australia, 2006
Australia, Queensland
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Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
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Adelaide, South Australia, Australia, 5005
Australia, Victoria
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Heidelberg West, Victoria, Australia, 3081
Austria
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Graz, Austria, 8036
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Salzburg, Austria, 5020
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Wien, Austria, 1090
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Wien, Austria, 1130
Belgium
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Boussu, Belgium, 7300
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Edegem, Belgium, 2650
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Liège, Belgium, 4000
Brazil
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-170
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Campinas, Sao Paulo, Brazil, 13073-350
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São Paulo, Sao Paulo, Brazil, 05403-000
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São Paulo, Sao Paulo, Brazil, 05403-900
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Curitiba, Brazil, 80030-110
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São Paulo, Brazil, 04022-002
Canada, Alberta
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Calgary, Alberta, Canada, T2T 5C7
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Edmonton, Alberta, Canada, T6G 2E1
Canada, Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 7L6
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Hamilton, Ontario, Canada, L8L 2X2
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Hamilton, Ontario, Canada, L8M 1K7
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Ottawa, Ontario, Canada, K1H 1A2
Canada, Quebec
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Pointe Claire, Quebec, Canada, H9R 4S3
Canada
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Quebec, Canada, G1V 4G2
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Quebec, Canada, G1V 4G5
Denmark
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Frederiksberg C, Denmark, 1958
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Hvidovre, Denmark, 2650
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Århus C, Denmark, 8000
Finland
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Helsinki, Finland, 00290
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Kuopio, Finland, 07100
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Oulu, Finland, 90029
Former Serbia and Montenegro
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Belgrade, Former Serbia and Montenegro, 11000
France
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Antibes, France, 06600
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Lille, France, 59037
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PARIS cedex 13, France, 75651
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Paris, France, 75877
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Pierre-Bénite, France, 69495
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Saint Herblain, France, 44800
Germany
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Bad Nauheim, Germany, 61231
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Berlin, Germany, 13055
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Dresden, Germany, 01219
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Duisburg, Germany, 47051
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Freiburg, Germany, 79106
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Giessen, Germany, 35392
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Gifhorn, Germany, 38518
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Leipzig, Germany, 04103
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Mannheim, Germany, 68163
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St. Ingbert, Germany, 66386
Hong Kong
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Shatin, New Territories, Hong Kong
Hungary
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Budapest, Hungary, H-1115
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Budapest, Hungary, H-1134
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Debrecen, Hungary, H-4012
India
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Bangalore, Karnataka, India, 560 017
Novo Nordisk Investigational Site
Belgaum, Karnataka, India, 590001
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 4000021
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Mumbai, Maharashtra, India, 400007
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400703
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411030
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Trichy, Tamil Nadu, India, 620018
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Karnal, India, 132001
Novo Nordisk Investigational Site
Kerala, India, 682026
Ireland
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Dublin 9, Ireland
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Dublin, Ireland, DUBLIN 4
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Dublin, Ireland, DUBLIN 8
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Galway, Ireland
Israel
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Ofakim, Israel, 87520
Novo Nordisk Investigational Site
Petah-Tikva, Israel, 49100
Novo Nordisk Investigational Site
Petah-Tikva, Israel, 49372
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 64239
Italy
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Bologna, Italy, 40138
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Firenze, Italy, 50139
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Milano, Italy, 20145
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Padova, Italy, 35128
Novo Nordisk Investigational Site
Palermo, Italy, 90127
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Pisa, Italy, 56124
Novo Nordisk Investigational Site
Roma, Italy, 00168
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Siena, Italy, 53100
Mexico
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Pachuca, Hidalgo, Mexico, 42084
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico, 03300
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico, 14000
Novo Nordisk Investigational Site
Tampico, Tamaulipas, Mexico, 89000
Novo Nordisk Investigational Site
Durango, Mexico, 34000
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Monterrey, Mexico, 64700
Netherlands
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Almere, Netherlands, 1311RL
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Amsterdam, Netherlands, 1066 EC
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Beek, Netherlands, 6191JW
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Hengelo OV, Netherlands, 7555 DL
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Hilversum, Netherlands, 1213 RH
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Leidschendam, Netherlands, 2262 BA
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Zwijndrecht, Netherlands, 3331 LZ
Norway
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Bergen, Norway, NO-5012
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Oslo, Norway, 0407
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Trondheim, Norway, 7030
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Tønsberg, Norway, 3117
Poland
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Bialystok, Poland, 15-381
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Katowice, Poland, 40-662
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Katowice, Poland, 40-767
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Poznan, Poland, 60-569
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Szczecin, Poland, 70-483
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Szczecin, Poland, 71-455
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
Russian Federation
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Arkhangelsk, Russian Federation, 163045
Novo Nordisk Investigational Site
Moscow, Russian Federation, 101990
Novo Nordisk Investigational Site
Moscow, Russian Federation, 115093
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 121356
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125367
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127486
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630047
Novo Nordisk Investigational Site
Tumen, Russian Federation, 625023
Serbia
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Belgrade, Serbia, 11000
South Africa
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Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0083
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7130
Spain
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Almería, Spain, 04001
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Madrid, Spain, 28006
Novo Nordisk Investigational Site
Santiago de Compostela, Spain, 15706
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Valladolid, Spain, 47005
Switzerland
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Baden-Dättwil, Switzerland, 5405
Novo Nordisk Investigational Site
Bern, Switzerland, 3010
Novo Nordisk Investigational Site
Genève 14, Switzerland, 1211
Novo Nordisk Investigational Site
St. Gallen, Switzerland, 9016
Novo Nordisk Investigational Site
Zollikerberg, Switzerland, 8125
Turkey
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Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Ankara, Turkey, 06110
Novo Nordisk Investigational Site
Istanbul, Turkey, 34098
Novo Nordisk Investigational Site
Istanbul, Turkey, 34371
Novo Nordisk Investigational Site
Istanbul, Turkey, 34668
Novo Nordisk Investigational Site
Istanbul, Turkey, 34760
United Kingdom
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Coventry, United Kingdom, CV2 2DX
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Glasgow, United Kingdom, G11 6NT
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2JZ
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Liverpool, United Kingdom, L9 7AL
Novo Nordisk Investigational Site
London, United Kingdom, SE1 9RT
Novo Nordisk Investigational Site
London, United Kingdom, W1T 7DN
Novo Nordisk Investigational Site
London, United Kingdom, W6 8RF
Novo Nordisk Investigational Site
Luton, United Kingdom, LU4 0DZ
Novo Nordisk Investigational Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry GCR, 1452 Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272219     History of Changes
Other Study ID Numbers: NN8022-1839  2008-001049-24  U1111-1118-7871 
Study First Received: January 6, 2011
Results First Received: January 22, 2015
Last Updated: November 7, 2016

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Prediabetic State
Glucose Intolerance
Overnutrition
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 20, 2017