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A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT01928329
Recruitment Status : Completed
First Posted : August 23, 2013
Results First Posted : October 22, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type I Diabetes
Interventions Drug: Exenatide (Bydureon®)
Drug: Placebo
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Period Title: Overall Study
Started 40 39
Completed 28 25
Not Completed 12 14
Reason Not Completed
Withdrew Consent Prior to Receiving Drug             1             3
Removed from Study Prior to Receiving Dr             0             1
Adverse Event             5             3
Stopping Rule: Lost Greater than 5kg             4             1
Withdrawal by Subject             1             5
Physician Decision             1             1
Arm/Group Title Exenatide (Bydureon) Placebo Total
Hide Arm/Group Description

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 40 39 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 39 participants 79 participants
38.55  (12.06) 33.49  (11.39) 36.05  (11.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Female
29
  72.5%
25
  64.1%
54
  68.4%
Male
11
  27.5%
14
  35.9%
25
  31.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
American Indian or Alaska Native
0
   0.0%
1
   2.6%
1
   1.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.0%
1
   2.6%
3
   3.8%
White
34
  85.0%
35
  89.7%
69
  87.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  10.0%
2
   5.1%
6
   7.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 39 participants 79 participants
40 39 79
C-Peptide Production   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Negative (< 0.05 ng/ml)
24
  60.0%
22
  56.4%
46
  58.2%
Positive (>= 0.05 ng/ml)
16
  40.0%
17
  43.6%
33
  41.8%
[1]
Measure Description: Participants were stratified in the randomization based on their ability to produce C-Peptide.
BMI (kg/m^2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 39 participants 79 participants
29.31  (6.35) 29.41  (6.34) 29.36  (6.31)
[1]
Measure Description: BMI was calculated as kg/m^2
Study Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Yale University
13
  32.5%
17
  43.6%
30
  38.0%
University of Michigan
6
  15.0%
4
  10.3%
10
  12.7%
University of Miami
0
   0.0%
3
   7.7%
3
   3.8%
University of Colorado: Denver
6
  15.0%
7
  17.9%
13
  16.5%
University of Chicago
3
   7.5%
3
   7.7%
6
   7.6%
University of California San Francisco
5
  12.5%
3
   7.7%
8
  10.1%
SUNY Upstate Medical University
4
  10.0%
0
   0.0%
4
   5.1%
Joslin Diabetes Center at HMS
3
   7.5%
2
   5.1%
5
   6.3%
1.Primary Outcome
Title Change From Baseline in HbA1c Levels
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description:

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Overall Number of Participants Analyzed 40 39
Least Squares Mean (Standard Error)
Unit of Measure: mmol/mol
-0.12  (0.08) 0.11  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Bydureon), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0816
Comments The <0.05 is the apriori threshold for statistical significance.
Method Mixed Models Analysis
Comments HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.50 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c Levels
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis.
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description:

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Overall Number of Participants Analyzed 40 39
Least Squares Mean (Standard Error)
Unit of Measure: mmol/mol
0.08  (0.09) 0.10  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Bydureon), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.912
Comments The <0.05 is the apriori threshold for statistical significance.
Method Mixed Models Analysis
Comments HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.28 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Major Hypoglycemic Event Rate On Drug
Hide Description The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only those randomized that received study drug.
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description:

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Overall Number of Participants Analyzed 39 35
Median (Full Range)
Unit of Measure: events per month
0.67
(0.00 to 13.00)
0.80
(0.00 to 10.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Bydureon), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.423
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Z score
Estimated Value -.801
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Major Hypoglycemic Event Rate Off Drug
Hide Description The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only those randomized that received study drug and were followed through study completion.
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description:

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

Overall Number of Participants Analyzed 37 26
Median (Full Range)
Unit of Measure: events per month
0.33
(0.00 to 5.00)
0.50
(0.00 to 13.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Bydureon), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Z score
Estimated Value -1.312
Estimation Comments [Not Specified]
Time Frame Up to 12 months.
Adverse Event Reporting Description Patients 'at risk' for all adverse events are the 'safety population'- which consists of any patient that received study drug post randomization. This would be a total of 74 of 79 patients, 39 in drug arm and 35 in placebo arm.
 
Arm/Group Title Exenatide (Bydureon) Placebo
Hide Arm/Group Description

2 mg, of drug administration 1 per week via subcutaneous self injection

Exenatide (Bydureon®)

2 mg, 1 per week via subcutaneous placebo self injection

Placebo

All-Cause Mortality
Exenatide (Bydureon) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
Exenatide (Bydureon) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/39 (15.38%)      2/35 (5.71%)    
General disorders     
Anaphylaxis *  0/39 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations     
Infections and infestations - Other *  1/39 (2.56%)  1 0/35 (0.00%)  0
Pelvic infection *  0/39 (0.00%)  0 1/35 (2.86%)  1
Urinary tract infection *  0/39 (0.00%)  0 1/35 (2.86%)  1
Metabolism and nutrition disorders     
Acidosis *  1/39 (2.56%)  2 0/35 (0.00%)  0
Hyperglycemia   1/39 (2.56%)  1 0/35 (0.00%)  0
Hypoglycemia   3/39 (7.69%)  6 0/35 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide (Bydureon) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/39 (100.00%)      28/35 (80.00%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders - Other *  2/39 (5.13%)  0/35 (0.00%) 
Eye disorders     
Conjunctivitis *  2/39 (5.13%)  0/35 (0.00%) 
Eye disorders - Other *  0/39 (0.00%)  2/35 (5.71%) 
Gastrointestinal disorders     
Abdominal Bloating *  1/39 (2.56%)  4/35 (11.43%) 
Bloating *  2/39 (5.13%)  2/35 (5.71%) 
Diarrhea *  3/39 (7.69%)  3/35 (8.57%) 
Dyspepsia *  3/39 (7.69%)  0/35 (0.00%) 
Gastrointestinal disorders - Other *  7/39 (17.95%)  3/35 (8.57%) 
Nausea *  13/39 (33.33%)  5/35 (14.29%) 
Vomiting *  8/39 (20.51%)  1/35 (2.86%) 
General disorders     
General disorders and administration site conditions - Other *  14/39 (35.90%)  7/35 (20.00%) 
Injection site reaction   4/39 (10.26%)  3/35 (8.57%) 
Tremors *  2/39 (5.13%)  0/35 (0.00%) 
Infections and infestations     
Infections and infestations - Other *  1/39 (2.56%)  3/35 (8.57%) 
Upper respiratory infection *  7/39 (17.95%)  5/35 (14.29%) 
Vaginal infection *  2/39 (5.13%)  2/35 (5.71%) 
Investigations     
Aspartate aminotransferase increased   1/39 (2.56%)  2/35 (5.71%) 
Metabolism and nutrition disorders     
Hyperglycemia   2/39 (5.13%)  0/35 (0.00%) 
Hypoglycemia   28/39 (71.79%)  23/35 (65.71%) 
Major Hypoglycemia   2/39 (5.13%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder - Other *  6/39 (15.38%)  4/35 (11.43%) 
Pain in extremity *  3/39 (7.69%)  0/35 (0.00%) 
Nervous system disorders     
Dizziness *  2/39 (5.13%)  0/35 (0.00%) 
Headache *  3/39 (7.69%)  6/35 (17.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  0/39 (0.00%)  3/35 (8.57%) 
Nasal congestion *  0/39 (0.00%)  4/35 (11.43%) 
Respiratory, thoracic and mediastinal disorders - Other *  2/39 (5.13%)  1/35 (2.86%) 
Skin and subcutaneous tissue disorders     
Pruritus   2/39 (5.13%)  4/35 (11.43%) 
Rash maculo-papular *  0/39 (0.00%)  3/35 (8.57%) 
Skin and subcutaneous tissue disorders - Other *  14/39 (35.90%)  6/35 (17.14%) 
Surgical and medical procedures - Other *  2/39 (5.13%)  0/35 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevan Herold, MD
Organization: C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology)
Phone: (203) 785-6507
EMail: kevan.herold@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01928329    
Other Study ID Numbers: 1307012371
First Submitted: August 19, 2013
First Posted: August 23, 2013
Results First Submitted: September 3, 2019
Results First Posted: October 22, 2019
Last Update Posted: March 19, 2020