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Sponsors and Collaborators: |
Joslin Diabetes Center Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
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Information provided by: | Joslin Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00353834 |
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-independent vasodilation, as measured by nitroglycerin (TNG) response, and to evaluate the effect on arterial stiffness, as measured by pulse wave analysis (PWA). We will also measure the effects on various markers of endothelial function, subclinical inflammation, fibrinolysis, and oxidative stress. The control group for the study will receive Lantus insulin, with a goal of similar glycemic control between the treatment and control groups.
Specific Aims
We will test the following hypotheses:
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: Exenatide Drug: Glargine Insulin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Exenatide Compared to Lantus Insulin on Vascular Function Before and After a Meal Tolerance Test in Patients With Type 2 Diabetes |
Estimated Enrollment: | 72 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Edward S. Horton, MD | 617 732-2428 | edward.horton@joslin.harvard.edu |
Contact: Allison Cohen, MD | 617 732 2428 | allison.cohen@joslin.harvard.edu |
Principal Investigator: | Edward S. Horton, MD | Joslin Diabetes Center |
Study ID Numbers: | CHS #05-45 |
Study First Received: | July 18, 2006 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00353834 History of Changes |
Health Authority: | United States: Institutional Review Board |
endothelial dysfunction subclinical inflammation flow mediated brachial artery dilation |
pulse wave analysis glucagon like polypeptide mimetics type 2 diabetes mellitus |
Metabolic Diseases Dilatation, Pathologic Exenatide Glucagon Diabetes Mellitus Endocrine System Diseases Insulin |
Inflammation Hypoglycemic Agents Diabetes Mellitus, Type 2 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |