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Adding Liraglutide to High Dose Insulin: Breaking the Cycle

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ClinicalTrials.gov Identifier: NCT01505673
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : December 15, 2017
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Obesity
Interventions Drug: Liraglutide
Drug: Saline
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months Saline: Placebo injection of 1.8mg saline once daily for 6-months
Period Title: Overall Study
Started 35 36
Completed 32 34
Not Completed 3 2
Arm/Group Title Liraglutide Saline Injection Total
Hide Arm/Group Description Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months Saline: Placebo injection of 1.8mg saline once daily for 6-months Total of all reporting groups
Overall Number of Baseline Participants 35 36 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
36
 100.0%
71
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 71 participants
52.8  (8.1) 55.5  (6.6) 54.2  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
Female
23
  65.7%
22
  61.1%
45
  63.4%
Male
12
  34.3%
14
  38.9%
26
  36.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants 36 participants 71 participants
32
  91.4%
34
  94.4%
66
  93.0%
1.Primary Outcome
Title Glycemic Control Measured by HbA1c
Hide Description HbA1c (%)
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: Percent HbA1c
7.9  (1.1) 8.9  (1.3)
2.Secondary Outcome
Title Pancreatic and Hepatic Triglyceride Content
Hide Description Liver Triglyceride and Pancreatic Triglyceride
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: Percent Triglyceride
Liver Triglyceride 12.3  (5.8) 12.2  (7.8)
Pancreatic Triglyceride 12.53  (8.13) 14.64  (9.25)
3.Secondary Outcome
Title Weight
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: Kilograms
114  (21) 117  (27)
4.Secondary Outcome
Title Beta-Cell Function
Hide Description Fasting Glucose as a Measure of Beta-Cell Function
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
179  (75) 197  (98)
5.Secondary Outcome
Title Glucagon
Hide Description Measured during mixed meal challenge test.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: pg/mL
107.3  (44.5) 93.8  (37.8)
6.Secondary Outcome
Title Total Daily Insulin Dose
Hide Description The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Median (Inter-Quartile Range)
Unit of Measure: IU
200
(163 to 275)
218
(160 to 260)
7.Secondary Outcome
Title Number of Daily Injections
Hide Description The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: number/day
3.7  (1.4) 3.8  (1.3)
8.Secondary Outcome
Title Blood Pressure
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic 134  (18) 135  (17)
Diastolic 80.5  (13.7) 74.3  (9.7)
9.Secondary Outcome
Title Lipid Profile
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total cholesterol 154  (41) 152  (42)
LDL 83.9  (37.2) 76.3  (28.4)
HDL 36.6  (9.8) 37.6  (9.9)
10.Secondary Outcome
Title Liver Function Blood Test
Hide Description [Not Specified]
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: U/L
ALT 25.8  (13.5) 36.0  (43.7)
AST 26.4  (17.6) 32.1  (30.0)
11.Secondary Outcome
Title Hypoglycemic Events
Hide Description Reported as hypoglycemic events per month by patient as any blood glucose <70 mg/dl or symptoms of hypoglycemia with blood glucose >70 mg/dl
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Median (Inter-Quartile Range)
Unit of Measure: events per month per patient
1.1
(0.7 to 1.7)
0.7
(0.5 to 1.2)
12.Secondary Outcome
Title Quality of Life Survey (QoL) - General Health Perception
Hide Description General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.1  (0.9) 3.6  (0.6)
13.Secondary Outcome
Title Beta-Cell Function
Hide Description Fasting C-peptide as a Measure of Beta-Cell Function
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: microgram/L
2.48  (1.18) 1.75  (1.19)
14.Secondary Outcome
Title Matsuda Index as a Measure of Beta Cell Function
Hide Description The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Inter-Quartile Range)
Unit of Measure: index
2.88
(1.67 to 3.70)
3.12
(1.78 to 9.70)
15.Secondary Outcome
Title Beta-cell Function
Hide Description AUC c-peptide
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: ug/(L/min)
1234.6  (588.6) 922.9  (470.5)
16.Secondary Outcome
Title Ratio (AUC C-peptide/AUC Glucose)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: Ratio
0.019  (0.010) 0.013  (0.008)
17.Secondary Outcome
Title AUC Glucose
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: mg/(dL/min)
71747  (22141) 79278  (29416)
18.Secondary Outcome
Title Quality of Life Survey (QoL) - Current Health Perception
Hide Description Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.1  (0.9) 2.6  (1.0)
19.Secondary Outcome
Title Quality of Life Survey (QoL) - Treatment Satisfaction
Hide Description Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.4  (0.8) 2.7  (0.7)
20.Secondary Outcome
Title Quality of Life Survey (QoL) - Treatment Impact
Hide Description Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.3  (0.5) 2.6  (0.7)
21.Secondary Outcome
Title Quality of Life Survey (QoL) - Social or Vocational Worry
Hide Description Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0–5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.5  (0.7) 1.0  (0.9)
22.Secondary Outcome
Title Quality of Life Survey (QoL) - Hypoglycemia Fear
Hide Description Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.9  (0.7) 2.0  (0.8)
23.Secondary Outcome
Title Quality of Life Survey (QoL) - Glycemia Control Perception
Hide Description Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1–7, where 1 - extremely controlled and 7 - not at all controlled.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.0  (1.0) 2.9  (1.0)
24.Secondary Outcome
Title Quality of Life Survey (QoL) - Lifestyle Flexibility
Hide Description Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.2  (0.9) 2.6  (0.7)
25.Secondary Outcome
Title Quality of Life Survey (QoL) - Social Stigma
Hide Description Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.5  (1.1) 2.4  (1.0)
26.Secondary Outcome
Title Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
Hide Description Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.6  (1.0) 2.3  (1.3)
27.Secondary Outcome
Title Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
Hide Description Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description:
Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline: Placebo injection of 1.8mg saline once daily for 6-months
Overall Number of Participants Analyzed 32 34
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.0  (0.5) 2.1  (1.3)
Time Frame 6 months
Adverse Event Reporting Description Not available
 
Arm/Group Title Liraglutide Saline Injection
Hide Arm/Group Description Liraglutide: Liraglutide 1.8mg injected subcutaneously from pen device once daily for 6-months Saline: Placebo injection of 1.8mg saline once daily for 6-months
All-Cause Mortality
Liraglutide Saline Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Saline Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      6/36 (16.67%)    
Cardiac disorders     
Atrial fibrilation   1/35 (2.86%)  1 0/36 (0.00%)  0
Stent placement   0/35 (0.00%)  0 2/36 (5.56%)  2
Gastrointestinal disorders     
Acute cholecystitis   0/35 (0.00%)  0 1/36 (2.78%)  1
Gastroenteritis   0/35 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
COPD exacerbation   0/35 (0.00%)  0 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders     
Cellulitis   0/35 (0.00%)  0 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Liraglutide Saline Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/35 (40.00%)      14/36 (38.89%)    
Gastrointestinal disorders     
Nausea   11/35 (31.43%)  11 7/36 (19.44%)  7
Diarrhea   4/35 (11.43%)  4 3/36 (8.33%)  3
Vomiting   2/35 (5.71%)  2 1/36 (2.78%)  1
Decreased in apetite   6/35 (17.14%)  6 4/36 (11.11%)  4
Abdominal discomfort   1/35 (2.86%)  1 1/36 (2.78%)  1
Increase of serum amylase   1/35 (2.86%)  1 1/36 (2.78%)  1
Nervous system disorders     
Headache   3/35 (8.57%)  3 5/36 (13.89%)  5
Respiratory, thoracic and mediastinal disorders     
Cough   1/35 (2.86%)  1 3/36 (8.33%)  3
Hoarseness   0/35 (0.00%)  0 1/36 (2.78%)  1
Shortness of breath   1/35 (2.86%)  1 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Ildiko Lingvay
Organization: University of Texas Southwestern Medical Center at Dallas
Phone: 214-648-2779
EMail: ildiko.lingvay@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01505673     History of Changes
Other Study ID Numbers: IIS-000235
First Submitted: January 4, 2012
First Posted: January 6, 2012
Results First Submitted: August 1, 2017
Results First Posted: December 15, 2017
Last Update Posted: January 16, 2018