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

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ClinicalTrials.gov Identifier: NCT01784965
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Gerald M Reaven, Stanford University

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
Enrollment 69

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Placebo Liraglutide
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 33 35
Completed 27 24
Not Completed 6 11
Reason Not Completed
Withdrawal by Subject             6             3
Adverse Event             0             8
Arm/Group Title Placebo Liraglutide Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 27 24 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 24 participants 51 participants
58  (8) 58  (7) 58  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 51 participants
Female
17
  63.0%
16
  66.7%
33
  64.7%
Male
10
  37.0%
8
  33.3%
18
  35.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 24 participants 51 participants
27 24 51
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 27 participants 24 participants 51 participants
31.9  (3.5) 31.9  (2.7) 31.9  (3.1)
1.Primary Outcome
Title Change in Weight Reported at 14 Weeks
Hide Description Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.
Time Frame Baseline and 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Liraglutide
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 24
Mean (95% Confidence Interval)
Unit of Measure: kg
-3.3
(-4.1 to -2.5)
-6.8
(-7.8 to -5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Liraglutide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H
Hide Description Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks
Time Frame Baseline, 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Liraglutide
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 24
Mean (95% Confidence Interval)
Unit of Measure: pmol/l x4 h
-7.3
(-17 to 2)
34
(21 to 48)
3.Secondary Outcome
Title Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction
Hide Description Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.
Time Frame Baseline, 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Liraglutide
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 27 24
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.8  (35.9) -57.5  (44.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35 0/33 0/33 0/33 0/33 0/33
All-Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/35 (22.86%)      0/33 (0.00%)    
Gastrointestinal disorders     
Intolerable gastrointestional side effects  3/35 (8.57%)  3 0/33 (0.00%)  0
Gallstones  1/35 (2.86%)  1 0/33 (0.00%)  0
General disorders     
fall  1/35 (2.86%)  1 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pneumonia  1/35 (2.86%)  1 0/33 (0.00%)  0
Skin and subcutaneous tissue disorders     
injection site reaction  2/35 (5.71%)  2 0/33 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/35 (8.57%)      6/33 (18.18%)    
Investigations     
protocol deviation  1/35 (2.86%)  1 0/33 (0.00%)  0
Family issues  1/35 (2.86%)  1 0/33 (0.00%)  0
Decided to withdraw  0/35 (0.00%)  0 6/33 (18.18%)  6
Surgical and medical procedures     
elective back surgery  1/35 (2.86%)  1 0/33 (0.00%)  0
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.
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
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