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Role of Exenatide in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00456300
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Rubina Heptulla, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Exenatide
Drug: Insulin
Enrollment 11
Recruitment Details 11 subjects were enrolled into the study. Of these, 9 subjects were randomized and only 8 subjects completed this three part study. These subjects were recruited from the diabetes clinics.
Pre-assignment Details Two subjects failed screening and could not be randomized to particiapate.
Arm/Group Title Insulin First, Then Exenatide1.25 mcg, Then Exenatide 2.5 mcg Insulin First, Then Exenatide 2.5 mcg, Then Exenatide 1.25 mcg
Hide Arm/Group Description Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 1.25 mcg + Insulin or Exenatide 2.5 mcg + Insulin Each of the eight study subjects underwent three study visits at-least 3 weeks apart; at each visit receiving either Insulin alone, Exenatide 2.5 mcg + Insulin or Exenatide 1.25 mcg + Insulin
Period Title: Overall Study
Started [1] 5 4
Completed 4 4
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
"Started" means recruited, not enrolled.
Arm/Group Title All Study Participants
Hide Arm/Group Description Following the baseline study with insulin, Participants were randomized to receive either Exenatide 1.25 mcg or Exenatide 2.5 mcg
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
17  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone
Hide Description Post-prandial blood glucose concentration in terms of mean AUC (0-120 min) was determined in subjects treated with either Exenatide 1.25 mcg or Exenatide 2.5 along with insulin, compared to insulin alone, given as a single subcutaneous injection
Time Frame 0-120 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of each intervention and completed all study visits were included in the analyses. Only 8 subjects completed all study visits and one dropped out during the second study visit.
Arm/Group Title Exenatide 1.25 mcg + Insulin Exenatide 2.5 mcg + Insulin Insulin Monotherapy
Hide Arm/Group Description:
Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection
Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection
Participants who received Insulin alone as a single subcutaneous injection, part of baseline study
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Error)
Unit of Measure: mmol*L/min
49  (156) 44  (281) 379  (259)
Time Frame 0-120 minutes post-dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide 1.25 mcg + Insulin Exenatide 2.5 mcg + Insulin Insulin Monotherapy
Hide Arm/Group Description Participants who received Exenatide 1.25 mcg along with Insulin as a single subcutaneous injection Participants who received Exenatide 2.5 mcg along with Insulin as a single subcutaneous injection Participants who received Insulin alone as a single subcutaneous injection, as part of the baseline study visit
All-Cause Mortality
Exenatide 1.25 mcg + Insulin Exenatide 2.5 mcg + Insulin Insulin Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide 1.25 mcg + Insulin Exenatide 2.5 mcg + Insulin Insulin Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide 1.25 mcg + Insulin Exenatide 2.5 mcg + Insulin Insulin Monotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/9 (0.00%)      0/9 (0.00%)    
Endocrine disorders       
Hypoglycemia   1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
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: Rubina Heptulla
Organization: Montefiore Medical College
Phone: 832824000
EMail: rubhep@gmail.com
Layout table for additonal information
Responsible Party: Rubina Heptulla, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00456300     History of Changes
Other Study ID Numbers: H-16488
First Submitted: April 3, 2007
First Posted: April 4, 2007
Results First Submitted: March 13, 2018
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019