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: March 5, 2015
Last verified: March 2015
Results First Received: January 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Metabolism and Nutrition Disorder
Obesity
Interventions: Drug: liraglutide
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 191 sites in 27 countries: Australia:4,Austria:3,Belgium:2, Brazil:5,Canada:11, Denmark:3,Finland:3, France:5, Germany:8,Hong Kong:1, Hungary:2, India:8, Ireland:1,Israel:7, Italy:7, Mexico:4, Netherlands:5, Norway:3, Poland:5, Russian:7, Serbia:2, South Africa:3, Spain:6, Switzerland:5,Turkey:40, UK:8, US:69.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomised in a 2:1 ratio to receive either liraglutide 3.0 mg or liraglutide placebo. Subjects were stratified based on pre-diabetes status at screening and further on baseline body mass index.

Reporting Groups
  Description
Liraglutide 3.0 mg, no Pre-diabetes Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68) Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68) Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
Liraglutide Placebo, no Pre-diabetes Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
Liraglutide 3.0 mg, Pre-diabetes Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
Liraglutide Placebo, Pre-diabetes Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.

Participant Flow for 2 periods

Period 1:   Main Period: Week 0 to Week 56
    Liraglutide 3.0 mg, no Pre-diabetes     Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)     Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)     Liraglutide Placebo, no Pre-diabetes     Liraglutide 3.0 mg, Pre-diabetes     Liraglutide Placebo, Pre-diabetes  
STARTED     959     0 [1]   0 [1]   487     1528     757  
Exposed     957     0     0     487     1524     755  
COMPLETED     679     0     0     296     1110     505  
NOT COMPLETED     280     0     0     191     418     252  
Adverse Event                 86                 0                 0                 16                 152                 29  
Lack of Efficacy                 11                 0                 0                 14                 12                 22  
Protocol Violation                 25                 0                 0                 18                 40                 20  
Withdrawal by Subject                 122                 0                 0                 114                 172                 147  
Unclassified                 36                 0                 0                 29                 42                 34  
[1] This arm is not considered for main period as these subjects belong to re-randomised period

Period 2:   Re-randomised Period: Week 56 to Week 68
    Liraglutide 3.0 mg, no Pre-diabetes     Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)     Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)     Liraglutide Placebo, no Pre-diabetes     Liraglutide 3.0 mg, Pre-diabetes     Liraglutide Placebo, Pre-diabetes  
STARTED     0 [1]   351 [2]   350 [2]   304 [2]   0 [1]   0 [1]
COMPLETED     0     342     343     289     0     0  
NOT COMPLETED     0     9     7     15     0     0  
Adverse Event                 0                 1                 1                 2                 0                 0  
Lack of Efficacy                 0                 0                 0                 1                 0                 0  
Protocol Violation                 0                 1                 0                 3                 0                 0  
Withdrawal by Subject                 0                 6                 4                 7                 0                 0  
Unclassified                 0                 1                 2                 2                 0                 0  
[1] This arm is not considered for re-randomised period as these subjects belong to main period.
[2] Due to incorrect stratification of subjects, some pre-diabetic subjects erroneously entered this arm



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Liraglutide 3.0 mg, no Pre-diabetes Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
Liraglutide Placebo, no Pre-diabetes Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
Liraglutide 3.0 mg, Pre-diabetes Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
Liraglutide Placebo, Pre-diabetes Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
Total Total of all reporting groups

Baseline Measures
    Liraglutide 3.0 mg, no Pre-diabetes     Liraglutide Placebo, no Pre-diabetes     Liraglutide 3.0 mg, Pre-diabetes     Liraglutide Placebo, Pre-diabetes     Total  
Number of Participants  
[units: participants]
  959     487     1528     757     3731  
Age  
[units: years]
Mean ± Standard Deviation
  41.6  ± 11.7     41.5  ± 11.5     47.4  ± 11.8     47.2  ± 11.8     45.1  ± 12.0  
Gender  
[units: participants]
         
Female     801     390     1156     581     2928  
Male     158     97     372     176     803  
Fasting Body Weight  
[units: kg]
Mean ± Standard Deviation
  104.0  ± 20.1     103.6  ± 21.2     107.6  ± 21.8     107.9  ± 21.8     106.2  ± 21.4  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  37.5  ± 6.2     37.4  ± 6.2     38.8  ± 6.4     39.0  ± 6.3     38.3  ± 6.4  
Glycosylated Haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  5.3  ± 0.3     5.3  ± 0.3     5.8  ± 0.3     5.7  ± 0.3     5.6  ± 0.4  
Fasting Plasma Glucose (FPG)  
[units: mmol/L]
Mean ± Standard Deviation
  5.0  ± 0.4     5.1  ± 0.5     5.5  ± 0.6     5.5  ± 0.5     5.3  ± 0.6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Fasting Body Weight   [ Time Frame: Week 0, Week 56 ]

2.  Primary:   Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.   [ Time Frame: At Week 56 ]

3.  Primary:   Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight.   [ Time Frame: At 56 weeks ]

4.  Secondary:   Change From Baseline in Waist Circumference (cm).   [ Time Frame: Week 0, Week 56 ]

5.  Secondary:   Pre-diabetes Status After 56 Weeks of Treatment.   [ Time Frame: Week 0, Week 56 ]

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

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

8.  Primary:   Proportion of Subjects With Onset of Type 2 Diabetes   [ Time Frame: at 160 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)   [ Time Frame: Week 0, week 160 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Change From Baseline in Pre-diabetes Status (Subjects With Pre-diabetes at Baseline)   [ Time Frame: Week 0, week 160 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Mean Change From Baseline in Body Weight (Subjects With Pre-diabetes at Baseline)   [ Time Frame: Week 0, week 160 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided


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: March 5, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Federal Office for Safety in Health Care
Switzerland: Swissmedic
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Healthcare Products
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Brazil: National Health Surveillance Agency
Hong Kong: Department of Health
India: Ministry of Health
Israel: Ministry of Health
Mexico: National Commission for the Prevention of Sanitary Risks
Russia: Federal Service for Control of Health Care and Social Development
South Africa: Medicines Control Council
Turkey: Ministry of Health
Hungary: National Institute of Pharmacy
Serbia: Medicines and Medical Devices Agency of Serbia
Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials
United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration