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Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01784965
First Posted: February 6, 2013
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University
Results First Submitted: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pre-diabetes
Older Adults
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 person qualified and enrolled in study but dropped out before being randomized to either group. Therefore is not counted in placebo or liraglutide group.

Reporting Groups
  Description
Placebo

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.

Liraglutide

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.


Participant Flow:   Overall Study
    Placebo   Liraglutide
STARTED   33   35 
COMPLETED   27   24 
NOT COMPLETED   6   11 
Withdrawal by Subject                6                3 
Adverse Event                0                8 



  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
Placebo

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.

Liraglutide

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.

Total Total of all reporting groups

Baseline Measures
   Placebo   Liraglutide   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   24   51 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (8)   58  (7)   58  (7.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  63.0%      16  66.7%      33  64.7% 
Male      10  37.0%      8  33.3%      18  35.3% 
Region of Enrollment 
[Units: Participants]
     
United States   27   24   51 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.9  (3.5)   31.9  (2.7)   31.9  (3.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Weight Reported at 14 Weeks   [ Time Frame: Baseline and 14 weeks ]

2.  Secondary:   Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H   [ Time Frame: Baseline, 14 weeks ]

3.  Secondary:   Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction   [ Time Frame: Baseline, 14 weeks ]


  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
Major limitation: the experimental groups were relatively small. In addition, 31% of individuals randomized to liraglutide discontinued participation. Other studies suggest tolerance of GLP-1 receptor agonists may vary by population characteristics.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Gerald Reaven, Professor Emeritus
Organization: Stanford Universtiy
phone: 650-724-3416
e-mail: greaven@stanford.edu


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

Responsible Party: Gerald M Reaven, Stanford University
ClinicalTrials.gov Identifier: NCT01784965     History of Changes
Other Study ID Numbers: 17394
First Submitted: February 4, 2013
First Posted: February 6, 2013
Results First Submitted: March 14, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017