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NCT00353834 · ClinicalTrials.gov registry record · Phase 4
The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes
A Phase 4 study, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT00353834 is a Phase 4 study that has completed, run by Joslin Diabetes Center. The registered enrollment target is 72 participants.
The verdict
NCT00353834, a Phase 4 study, has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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-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: 1. Treatment of patients with type 2 diabetes who are inadequately controlled by monotherapy with a Sulfonylurea (SU) or Metformin, or on combination therapy of a SU and Metformin with Exenatide (GLP-1 mimetic) will result in improved endothelial dependent vasodilation, as measured by FMD, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 2. Treatment with Exenatide (GLP-1 mimetic) will result in improved arterial stiffness, as measured by AI by PWA, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 3. Endothelial dependent vasodilation, as measured by FMD, and arterial stiffness, as measured by AI, measured in the postprandial state (following a standard test meal) will be improved following treatment with Exenatide as compared to treatment with once daily basal insulin (Lantus). 4. Treatment will result in no improvement in endothelial-independent vasodilation, as measured by a response to TNG, as compared to the control group, who will be treated with Lantus insulin to achieve comparable HbA1c levels. 5. Treatment with Exenatide, compared with treatment with Lantus, will result in a reduction in various plasma markers of inflammation (CRP, TNFA, IL6), endothelial acti
Interventions
- DRUG Exenatide
- DRUG Glargine Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00353834
The ClinicalTrials.gov registry entry for NCT00353834 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joslin Diabetes Center, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Exenatide is the first listed.
NCT00353834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00353834 about?
NCT00353834 is a clinical study titled "The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes". 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 ...
What is the current status of trial NCT00353834?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2006-08. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00353834?
The interventions under investigation include: Exenatide (DRUG), Glargine Insulin (DRUG).
Who is sponsoring clinical trial NCT00353834?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
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