Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272232
First received: January 6, 2011
Last updated: January 22, 2015
Last verified: January 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 126 sites in 9 countries participated: France (7), Germany (10), Israel (5), South Africa (6), Spain (8), Sweden (5), Turkey (3), United Kingdom (15), United States (67).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If eligible based on screened assessments, subjects were randomised to 1 of the 3 treatment arms in a 2:1:1 manner (liraglutide 3.0 mg, liraglutide 1.8 mg and placebo, respectively).

Reporting Groups
  Description
Liraglutide 3.0 mg Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Liraglutide 1.8 mg Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Liraglutide Placebo Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Participant Flow for 2 periods

Period 1:   Weeks 0-56
    Liraglutide 3.0 mg     Liraglutide 1.8 mg     Liraglutide Placebo  
STARTED     423     211     212  
Exposed     422 [1]   210 [1]   212  
COMPLETED     324     164     140  
NOT COMPLETED     99     47     72  
Adverse Event                 39                 18                 7  
Lack of Efficacy                 0                 0                 3  
Protocol Violation                 12                 8                 13  
Withdrawal criteria                 32                 14                 37  
Unclassified                 16                 7                 12  
[1] 1 subject dropped out after randomisation and before exposure to trial drug.

Period 2:   Off Drug Follow-up Period (Weeks 56-68)
    Liraglutide 3.0 mg     Liraglutide 1.8 mg     Liraglutide Placebo  
STARTED     324     164     140  
COMPLETED     310     154     135  
NOT COMPLETED     14     10     5  
Adverse Event                 1                 1                 0  
Lack of Efficacy                 1                 0                 0  
Protocol Violation                 1                 0                 1  
Withdrawal criteria                 9                 7                 4  
Unclassified                 2                 2                 0  



  Baseline Characteristics
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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 Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Liraglutide 1.8 mg Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Liraglutide Placebo Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Total Total of all reporting groups

Baseline Measures
    Liraglutide 3.0 mg     Liraglutide 1.8 mg     Liraglutide Placebo     Total  
Number of Participants  
[units: participants]
  423     211     212     846  
Age  
[units: years]
Mean ± Standard Deviation
  55.0  ± 10.8     54.9  ± 10.7     54.7  ± 9.8     54.9  ± 10.5  
Gender  
[units: participants]
       
Female     203     103     115     421  
Male     220     108     97     425  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     46     17     24     87  
Not Hispanic or Latino     375     194     187     756  
Unknown or Not Reported     2     0     1     3  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     4     0     0     4  
Asian     11     4     4     19  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     44     27     27     98  
White     353     177     175     705  
More than one race     0     0     0     0  
Unknown or Not Reported     11     3     6     20  
Age group  
[units: participants]
       
18- < 40 years     38     15     13     66  
40- < 65 years     300     162     161     623  
65- < 75 years     74     32     36     142  
> 75 years     11     2     2     15  
Fasting body weight [1]
[units: kg]
Mean ± Standard Deviation
  105.7  ± 21.9     105.8  ± 21.0     106.5  ± 21.3     105.9  ± 21.5  
Height [2]
[units: m]
Mean ± Standard Deviation
  1.69  ± 0.11     1.69  ± 0.10     1.69  ± 0.10     1.69  ± 0.10  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  37.1  ± 6.5     37.0  ± 6.9     37.4  ± 7.1     37.1  ± 6.8  
Body Mass Index (BMI) group  
[units: participants]
       
25.0-29.9 kg/m^2 - pre-obese     52     34     30     116  
30.0-34.9 kg/m^2 - obese class I     139     62     59     260  
35.0-39.9 kg/m^2 - obese class II     108     50     60     218  
>40.0 kg/m^2 - obese class III     124     65     63     252  
HbA1c (glycosylated haemoglobin)  
[units: Percent¬†(%)¬†glycosylated¬†haemoglobin]
Mean ± Standard Deviation
  7.9  ± 0.8     8.0  ± 0.8     7.9  ± 0.8     7.9  ± 0.8  
Fasting plasma glucose  
[units: mmol/L]
Mean ± Standard Deviation
  8.8  ± 1.9     8.9  ± 2.0     8.6  ± 1.8     8.8  ± 1.9  
Co-morbid hypertension [3]
[units: participants]
       
Present     293     148     145     586  
Absent     130     63     67     260  
Co-morbid dyslipidaemia [4]
[units: participants]
       
Present     295     143     126     564  
Absent     128     68     86     282  
Duration of diabetes  
[units: years]
Mean ± Standard Deviation
  7.54  ± 5.65     7.43  ± 5.16     6.71  ± 5.07     7.30  ± 5.39  
[1] Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
[2] Height was recorded without shoes.
[3] Presence or absence of untreated or treated hypertension
[4] Presence or absence of untreated or treated dyslipidaemia



  Outcome Measures
  Show All Outcome Measures

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

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

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

4.  Secondary:   Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)   [ Time Frame: Week 0, week 56 ]

5.  Secondary:   Proportion of Subjects Reaching Target HbA1c Below 7%   [ Time Frame: at 56 weeks ]

6.  Secondary:   Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%   [ Time Frame: at 56 weeks ]

7.  Secondary:   Change From Baseline in Waist Circumference   [ Time Frame: Week 0, week 56 ]

8.  Secondary:   Change (%) From Baseline in Body Weight (Fasting)   [ Time Frame: Week 0, week 68 ]

9.  Secondary:   Change (%) From Week 56 to 68 in Body Weight (Fasting)   [ Time Frame: Week 56, week 68 ]

10.  Secondary:   Change From Baseline in Waist Circumference   [ Time Frame: Week 0, week 68 ]

11.  Secondary:   Change From Week 56 to 68 in Waist Circumference   [ Time Frame: Week 56, week 68 ]

12.  Secondary:   Incidence of Hypoglycaemic Episodes   [ Time Frame: Weeks 0-56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT01272232     History of Changes
Other Study ID Numbers: NN8022-1922, 2008-002199-88, U1111-1118-7963
Study First Received: January 6, 2011
Results First Received: January 22, 2015
Last Updated: January 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration