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NCT00064714 · ClinicalTrials.gov registry record · Phase 2
Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT00064714 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 47 participants.
The verdict
NCT00064714, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study. They must have had diabetes for at least 5 years and require insulin treatment. Candidates will be screened with a questionnaire, followed by medical history and physical examination, blood and urine tests, a chest x-ray and skin test for tuberculosis, electrocardiogram (EKG), and arginine stimulated C-peptide test (see description below). Participants will undergo the following tests and procedures: Advanced screening phase: Participants undergo a diabetes education program, including instruction on frequent blood glucose monitoring, dietary education on counting carbohydrates, intensive insulin therapy, review of signs and symptoms of low blood sugar (hypoglycemia), and potential treatment with glucagon shots. Patients must administer insulin via an insulin pump or take at least four injections per day including glargine (Lantus) insulin. 4-month run-in phase * Arginine-stimulated C-peptide test: This test measures the body's insulin production. The patient is injected with a liquid containing arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. * Mixed meal stimulated C-peptid
Interventions
- DRUG AC2993 (exenatide)
- DRUG daclizumab (immunosuppressive)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064714
The ClinicalTrials.gov registry entry for NCT00064714 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AC2993 (exenatide) is the first listed.
NCT00064714 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064714 about?
NCT00064714 is a clinical study titled "Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes". This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function. Type I diabetes is an autoimmune disease, in which the immune system attacks the beta cells of t...
What is the current status of trial NCT00064714?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2003-07. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00064714?
The interventions under investigation include: AC2993 (exenatide) (DRUG), daclizumab (immunosuppressive) (DRUG).
Who is sponsoring clinical trial NCT00064714?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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