Status:
COMPLETED
The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on endothelial-independen...
Detailed Description
The trial is a randomized, controlled, comparator study. Subjects and investigators will not be blinded due to the nature of the treatment. After providing informed consent and meeting the inclusion a...
Eligibility Criteria
Inclusion
- age 18-75
- Type 2 Diabetes (diagnosed at least 3 months prior to study)
- HbA1c: above 7.0 and less than or equal to 10.0
- At least one HbA1c over preceding 3-6 months, and HbA1c at screening, with less than 1% difference between lowest and highest values
- Stable doses of antidiabetic medications (SU and/or Metformin) for 3 months
- reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile
- postmenopausal woman
- stable weight for 3 months prior to study (+/- 2kg)
- willingness to participate in the study
Exclusion
- Type 1 diabetes
- Type 2 diabetes less than 3 months in duration
- HbA1c less than 7.0 or greater than 10
- age less than 18 or greater than 75
- pregnant or planning to become pregnant during study period
- current insulin therapy or insulin within 6 months prior to study
- current use of Thiazolidinedione or within 6 months prior to study
- current use of Nateglinide or Repaglinide
- current use of an Alpha-glucosidase Inhibitor
- current weight loss program
- active smoker, or quit smoking within preceding 6 months
- creatinine greater than 2.0 mg/dL
- total cholesterol greater than 300 mg/dL
- triglycerides greater than 600 mg/dL
- blood pressure greater than 160/105 mmHg
- ALT/AST greater than twice the upper limit of normal
- any other medical condition that may interfere with trial participation or trial results
- if on Statin: Statin therapy for less than 3 months or dose change within preceding 3 months
- if on ACE Inhibitor: ACE Inhibitor therapy for less than 3 months or dose change within preceding 3 months
- current use of any medication that is known to alter gastric motility
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00353834
Start Date
August 1 2006
End Date
September 1 2010
Last Update
January 9 2018
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215