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NCT01269034 · ClinicalTrials.gov registry record · Phase 4
New Onset Type 1 Diabetes: Role of Exenatide
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT01269034 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT01269034, a Phase 4 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.
Interventions
- DRUG Exenatide
- DRUG Rapid and long acting insulin
- DRUG long acting insulin + rapid acting + 1.25 mcg Exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01269034
The ClinicalTrials.gov registry entry for NCT01269034 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exenatide is the first listed.
NCT01269034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01269034 about?
NCT01269034 is a clinical study titled "New Onset Type 1 Diabetes: Role of Exenatide". There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test...
What is the current status of trial NCT01269034?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2010-12. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT01269034?
The interventions under investigation include: Exenatide (DRUG), Rapid and long acting insulin (DRUG), long acting insulin + rapid acting + 1.25 mcg Exenatide (DRUG).
Who is sponsoring clinical trial NCT01269034?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
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