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The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00353834
Recruitment Status : Completed
First Posted : July 19, 2006
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Exenatide
Drug: Glargine Insulin
Enrollment 72
Recruitment Details

Subjects were recruited from the Joslin Diabetes Center Clinic, Boston, MA, from July 2006-0ctober 2009. Subjects had Type 2 diabetes, treated with either Metformin, SU, Metformin/SU, TZD, or Metformin/TZD, on stable therapy and weight for 3 months.

The healthy controls in the Extension Study, were recruited from the Joslin Diabetes Center.

Pre-assignment Details Baseline fasting studies on all subjects included anthropometrics, blood pressure, HbA1c, glucose, insulin, c-peptide, lipids, free fatty acids (FFA), hsCRP, TNFa, IL-6, siCAM, sVCAM, PAI-1 antigen, and oxidized LDL. PWA and FMD were measured fasting and after a standardized meal with repeat PWA and FMD at 2 and 4 hours, and TNG at 4 hours.
Arm/Group Title Glargine Insulin Exenatide
Hide Arm/Group Description

Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.

Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.

Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks

Period Title: Overall Study
Started 26 27
Completed 26 27
Not Completed 0 0
Arm/Group Title Glargine Insulin Exenatide Total
Hide Arm/Group Description

Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.

Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.

Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 26 27 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
27
 100.0%
53
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 53 participants
60.4  (8.5) 58.4  (11.6) 59.4  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Female
10
  38.5%
12
  44.4%
22
  41.5%
Male
16
  61.5%
15
  55.6%
31
  58.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 27 participants 53 participants
26 27 53
1.Primary Outcome
Title The Primary Endpoint Was the Change in FMD at the End of the Study Compared to Baseline Measurements in Subjects Treated With Exenatide Compared to Subjects Treated With Lantus.
Hide Description Flow mediated dilation (FMD) of the brachial artery was measured at rest and during reactive hyperemia using a high-resolution 10.0 MHz linear array transducer and an HOI Ultramark 9 system. Reactive hyperemia was produced by inflating a pneumatic tourniquet on the forearm distal to the brachial artery to 50 mmHg above the systolic BP for 5 minutes, then deflating it . Brachial artery diameter was measured before inflation of the cuff and 1-2 minutes after cuff deflation and expressed as the percentage change. This protocol is described in detail elsewhere. This was performed fasting, 2, and 4 hours after the meal challenge at baseline and 3 months.
Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine Insulin Exenatide
Hide Arm/Group Description:

Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.

Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.

Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks

Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage dilation
5.0  (2.3) 4.7  (2.4)
2.Secondary Outcome
Title First Will be the Changes in TNG Stimulated Arterial Dilation (Endothelial-independent) in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements
Hide Description Trinitroglycerin (TNG) response evaluates endothelium independent vasodilation. The brachial artery was scanned before and 5 minutes after sublingual administration of 400 ug of trinitroglycerin. This was performed only at 4 hours following the test meal and fifteen minutes after completion of the FMD study to allow for the brachial artery to return to baseline. This was performed at both the baseline and 3 month visits.
Time Frame Baseline and end of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine Insulin Exenatide
Hide Arm/Group Description:

Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.

Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.

Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks

Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage dilation
10.7  (5.3) 11.3  (4.5)
3.Secondary Outcome
Title Second Will be the Change in Arterial Stiffness, as Measured by PWA, in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurements.
Hide Description [Not Specified]
Time Frame Baseline and end of study
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Third Will be the Changes in Markers of Endothelial Function, Inflammation, Fibrinolysis, and Oxidative Stress in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline
Hide Description [Not Specified]
Time Frame Baseline and end of study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Fourth Will be Changes in Insulin, Glucose, C-peptide, Lipids, and FFA Responses Following the MTT in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurement
Hide Description [Not Specified]
Time Frame Baseline and end of study
Outcome Measure Data Not Reported
Time Frame 3 years and 3 months
Adverse Event Reporting Description No adverse events reported
 
Arm/Group Title Glargine Insulin Exenatide
Hide Arm/Group Description

Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia.

Glargine Insulin: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia.

Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks.

Exenatide: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks

All-Cause Mortality
Glargine Insulin Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glargine Insulin Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glargine Insulin Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/27 (0.00%) 
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: Edward S. Horton, MD
Organization: Joslin Diabetes Center
Phone: 6173091995
EMail: edward.horton@joslin.harvard.edu
Layout table for additonal information
Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00353834     History of Changes
Other Study ID Numbers: CHS #05-45
First Submitted: July 18, 2006
First Posted: July 19, 2006
Results First Submitted: December 7, 2017
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018