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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: August 18, 2016
Last verified: August 2016
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 
Overall Participants Analyzed 
[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) 
[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.
Height [1] 
[Units: m]
Mean (Standard Deviation)
 1.69  (0.11)   1.69  (0.10)   1.69  (0.10)   1.69  (0.10) 
[1] Height was recorded without shoes.
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 [1] 
[Units: Participants]
       
Present   293   148   145   586 
Absent   130   63   67   260 
[1] Presence or absence of untreated or treated hypertension
Co-morbid dyslipidaemia [1] 
[Units: Participants]
       
Present   295   143   126   564 
Absent   128   68   86   282 
[1] Presence or absence of untreated or treated dyslipidaemia
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 7.54  (5.65)   7.43  (5.16)   6.71  (5.07)   7.30  (5.39) 


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232     History of Changes
Other Study ID Numbers: NN8022-1922
2008-002199-88 ( EudraCT Number )
U1111-1118-7963 ( Other Identifier: WHO )
Study First Received: January 6, 2011
Results First Received: January 22, 2015
Last Updated: August 18, 2016
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