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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

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ClinicalTrials.gov Identifier: NCT01272219
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : February 9, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 6, 2011
First Posted Date  ICMJE January 7, 2011
Results First Submitted Date  ICMJE January 22, 2015
Results First Posted Date  ICMJE February 9, 2015
Last Update Posted Date January 19, 2018
Actual Study Start Date  ICMJE June 1, 2011
Actual Primary Completion Date March 18, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
  • Change from baseline in body weight (fasting) [ Time Frame: Week 0, Week 56 ]
  • Proportion of subjects losing at least 5% of baseline body weight [ Time Frame: at 56 weeks ]
  • Proportion of subjects losing more than 10% of baseline body weight [ Time Frame: At 56 weeks ]
  • Proportion of Subjects With Onset of Type 2 Diabetes [ Time Frame: At 160 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2011)
  • Change from baseline in waist circumference [ Time Frame: Week 0, Week 56 ]
  • Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ]
  • Change from baseline in pre-diabetes status [ Time Frame: Week 0, Week 56 ]
  • Change From Baseline in Pre-diabetes Status (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ]
  • Mean Change From Baseline in Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: Week 0, week 160 ]
  • Proportion of Subjects Losing at Least 5% and More Than 10% of Baseline Body Weight (Subjects With Pre-diabetes at Baseline) [ Time Frame: At 160 weeks ]
  • Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes) [ Time Frame: Week 56, Week 68 ]
  • Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes) [ Time Frame: Week 0, Week 68 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
Official Title  ICMJE 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
Brief 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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolism and Nutrition Disorder
  • Obesity
Intervention  ICMJE
  • 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).
  • 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).
  • Drug: liraglutide
    Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
  • Drug: placebo
    Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
Study Arms  ICMJE
  • Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
    Intervention: Drug: liraglutide
  • Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
    Intervention: Drug: placebo
  • Placebo Comparator: Liraglutide Placebo, no Pre-diabetes
    Intervention: Drug: placebo
  • Experimental: Liraglutide 3.0mg, Pre-diabetes
    Intervention: Drug: liraglutide
  • Placebo Comparator: Liraglutide Placebo, Pre-diabetes
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2015)
3731
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2011)
3600
Actual Study Completion Date  ICMJE March 2, 2015
Actual Primary Completion Date March 18, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01272219
Other Study ID Numbers  ICMJE NN8022-1839
2008-001049-24 ( EudraCT Number )
U1111-1118-7871 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry GCR, 1452 Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP