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NCT00804297 · ClinicalTrials.gov registry record · Phase 3
Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia
A Phase 3 study, sponsored by Albert Einstein Healthcare Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT00804297 is a Phase 3 study that has completed, run by Albert Einstein Healthcare Network. The registered enrollment target is 40 participants.
The verdict
NCT00804297, a Phase 3 study, has completed, sponsored by Albert Einstein Healthcare Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
Background: Hypoglycemia is a common presentation to the Emergency Department. Management has traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often times be treated as outlined above and safely discharged to home after a period of short observation in the Emergency Department. This procedure is also followed in the pre-hospital care arena, where insulin-dependent hypoglycemic patients are often treated and released. In addition to diet-control and insulin, patients with diabetes maintain outpatient euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate insulin release from pancreatic beta cells via a complex mechanism culminating in calcium influx and release of stored insulin from secretory granules within the pancreas. Whereas insulin-dependent diabetic patients are usually discharged home after establishing normal blood glucose levels, hospital admission is generally recommended in hypoglycemic patients taking oral sulfonylureas due to the long duration of effect and delayed clearance of the drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic episodes. Octreotide is a somatostatin analog that is known to suppress numerous hormones including insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports and one prospective study in healthy volunteers have demonstrated the safety and efficacy of octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based largely on the results of these studies some experts in field of toxicology have argued that administration of octreotide be standard therapy for all patients with recurrent hyp
Interventions
- DRUG Octreotide (drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00804297
The ClinicalTrials.gov registry entry for NCT00804297 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein Healthcare Network, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Octreotide (drug) is the first listed.
NCT00804297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00804297 about?
NCT00804297 is a clinical study titled "Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia". Background: Hypoglycemia is a common presentation to the Emergency Department. Management has traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often times be treated as o...
What is the current status of trial NCT00804297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2005-06. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00804297?
The interventions under investigation include: Octreotide (drug) (DRUG).
Who is sponsoring clinical trial NCT00804297?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
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