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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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: SCALEā„¢ - 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 - The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
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. - Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Timepoint [2] 0 0
At Week 56
Primary outcome [3] 0 0
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).
Timepoint [3] 0 0
At 56 weeks
Primary outcome [4] 0 0
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).
Timepoint [4] 0 0
At 160 weeks
Secondary outcome [1] 0 0
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).
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) - 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).
Timepoint [2] 0 0
Week 0, week 160
Secondary outcome [3] 0 0
Pre-diabetes Status After 56 Weeks of Treatment - Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
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 - 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).
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) - 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).
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) - 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).
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) - 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).
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) - 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).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01272219
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

Summary results
Other publications