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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
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
Secondary ID [1] 0 0
2008-001049-24
Secondary ID [2] 0 0
NN8022-1839
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Fasting Body Weight
Timepoint [1] 0 0
Week 0, Week 56
Primary outcome [2] 0 0
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Timepoint [2] 0 0
At Week 56
Primary outcome [3] 0 0
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
Timepoint [3] 0 0
At 56 weeks
Primary outcome [4] 0 0
Proportion of Subjects With Onset of Type 2 Diabetes
Timepoint [4] 0 0
At 160 weeks
Secondary outcome [1] 0 0
Change From Baseline in Waist Circumference (cm)
Timepoint [1] 0 0
Week 0, Week 56
Secondary outcome [2] 0 0
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
Timepoint [2] 0 0
Week 0, week 160
Secondary outcome [3] 0 0
Pre-diabetes Status After 56 Weeks of Treatment
Timepoint [3] 0 0
Week 0, Week 56
Secondary outcome [4] 0 0
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
Timepoint [4] 0 0
Week 0, week 160
Secondary outcome [5] 0 0
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Timepoint [5] 0 0
Week 0, week 160
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
At 160 weeks
Secondary outcome [7] 0 0
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Timepoint [7] 0 0
Week 56, Week 68
Secondary outcome [8] 0 0
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Timepoint [8] 0 0
Week 0, Week 68

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/03/2015
Sample size
Target
Accrual to date
Final
3731
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - University Of Sydney
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Woolloongabba
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Heidelberg West
Recruitment postcode(s) [1] 0 0
2006 - University Of Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5005 - Adelaide
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment outside Australia
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry GCR, 1452
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorn... [More Details]
Journal Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Li... [More Details]
Journal O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, ... [More Details]
Journal Fujioka K, O'Neil PM, Davies M, Greenway F, C W La... [More Details]
Journal Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, J... [More Details]
Journal Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, ... [More Details]
Journal Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halp... [More Details]
Journal McEvoy BW. Missing data in clinical trials for wei... [More Details]
Journal Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T... [More Details]
Journal le Roux CW, Astrup A, Fujioka K, Greenway F, Lau D... [More Details]
Journal von Scholten BJ, Davies MJ, Persson F, Hansen TW, ... [More Details]
Journal O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW,... [More Details]
Journal Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jac... [More Details]
Journal Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujiok... [More Details]
Journal le Roux C, Aroda V, Hemmingsson J, Cancino AP, Chr... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01272219