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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01272219
Registration number
NCT01272219
Ethics application status
Date submitted
6/01/2011
Date registered
7/01/2011
Date last updated
19/01/2018
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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2008-001049-24
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Secondary ID [2]
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NN8022-1839
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder
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0
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Obesity
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Condition category
Condition code
Diet and Nutrition
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0
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0
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Obesity
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Metabolic and Endocrine
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0
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0
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Other metabolic disorders
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Metabolic and Endocrine
0
0
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) -
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) -
Placebo comparator: Liraglutide Placebo, no Pre-diabetes -
Experimental: Liraglutide 3.0mg, Pre-diabetes -
Placebo comparator: Liraglutide Placebo, Pre-diabetes -
Treatment: Drugs: 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).
Treatment: Drugs: 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).
Treatment: Drugs: liraglutide
Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Treatment: Drugs: placebo
Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Fasting Body Weight
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Assessment method [1]
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The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
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Timepoint [1]
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Week 0, Week 56
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Primary outcome [2]
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Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
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Assessment method [2]
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Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
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Timepoint [2]
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At Week 56
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Primary outcome [3]
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Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
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Assessment method [3]
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Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
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Timepoint [3]
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At 56 weeks
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Primary outcome [4]
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Proportion of Subjects With Onset of Type 2 Diabetes
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Assessment method [4]
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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).
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Timepoint [4]
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At 160 weeks
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Secondary outcome [1]
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Change From Baseline in Waist Circumference (cm)
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Assessment method [1]
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The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).
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Timepoint [1]
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Week 0, Week 56
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Secondary outcome [2]
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Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
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Assessment method [2]
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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).
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Timepoint [2]
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Week 0, week 160
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Secondary outcome [3]
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Pre-diabetes Status After 56 Weeks of Treatment
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Assessment method [3]
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Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
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Timepoint [3]
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Week 0, Week 56
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Secondary outcome [4]
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Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
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Assessment method [4]
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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).
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Timepoint [4]
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Week 0, week 160
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Secondary outcome [5]
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Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
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Assessment method [5]
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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).
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Timepoint [5]
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Week 0, week 160
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Secondary outcome [6]
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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)
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Assessment method [6]
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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).
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Timepoint [6]
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At 160 weeks
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Secondary outcome [7]
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Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
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Assessment method [7]
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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).
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Timepoint [7]
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Week 56, Week 68
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Secondary outcome [8]
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Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
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Assessment method [8]
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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).
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Timepoint [8]
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Week 0, Week 68
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/03/2015
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Sample size
Target
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Accrual to date
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Final
3731
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - University Of Sydney
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Woolloongabba
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Novo Nordisk Investigational Site - Adelaide
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - Heidelberg West
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Recruitment postcode(s) [1]
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2006 - University Of Sydney
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5005 - Adelaide
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Recruitment postcode(s) [4]
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3081 - Heidelberg West
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Recruitment outside Australia
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Former Serbia and Montenegro
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Funding & Sponsors
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Novo Nordisk A/S
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01272219
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Trial related presentations / publications
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. 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. doi: 10.1007/s40262-016-0410-7. 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 AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2. Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn 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 Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629. 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. 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. 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 Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892. McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth 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. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11. le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjoth 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 weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. Erratum In: Lancet. 2017 Apr 8;389(10077):1398. doi: 10.1016/S0140-6736(17)30705-5. 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: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11. 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 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21. 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 obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1. 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.12226. Epub 2017 Oct 16. 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/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17. Williams DM, Staff M, Bain SC, Min T. Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity. touchREV Endocrinol. 2022 Mar;18(1):43-48. doi: 10.17925/EE.2022.18.1.43. Epub 2022 Mar 18.
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Public notes
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Contacts
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Global Clinical Registry GCR, 1452
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Novo Nordisk A/S
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Results publications and other study-related documents
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Citations or Other Details
Journal
Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorn...
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Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Li...
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O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, ...
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Fujioka K, O'Neil PM, Davies M, Greenway F, C W La...
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Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, J...
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Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, ...
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Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halp...
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McEvoy BW. Missing data in clinical trials for wei...
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Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T...
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le Roux CW, Astrup A, Fujioka K, Greenway F, Lau D...
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von Scholten BJ, Davies MJ, Persson F, Hansen TW, ...
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O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW,...
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Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jac...
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Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujiok...
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le Roux C, Aroda V, Hemmingsson J, Cancino AP, Chr...
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Results are available at
https://clinicaltrials.gov/study/NCT01272219
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