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NCT00085982 · ClinicalTrials.gov registry record · Phase 2
Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance
A Phase 2 study of Severe Insulin Resistance, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Active
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT00085982 is a Phase 2 study of Severe Insulin Resistance that is active but no longer recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 11 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00085982, a Phase 2 study of Severe Insulin Resistance, is active but no longer recruiting, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control with conventional therapies, leading to early morbidity and mortality. We hypothesize that recombinant leptin (metreleptin) in these patients will improve glycemia control. Objectives: Primary Objective: To determine if 1 year of metreleptin will improve glycemia control in patients with genetic defects of the insulin receptor. Secondary Objectives: To determine mechanisms by which metreleptin improves glycemia. Endpoints: Primary Endpoint: Hemoglobin A1c. Secondary Endpoints: fasting plasma glucose, fasting insulin/C-peptide, glucose/insulin/C-peptide area under the curve during oral glucose tolerance test. Study Population: 20 male or female patients with mutations of the insulin receptor, age (Bullet)5 years, at the NIH Clinical Center. Description of Sites/Facilities Enrolling Participants: Description of Study Intervention: NIH Clinical Center Open label study of metreleptin, 0.2 mg/kg/day (max dose 0.24 mg/kg/day).
Conditions Studied
Interventions
- DRUG Metreleptin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2003-08-21 |
| Est. Completion | 2030-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00085982
The ClinicalTrials.gov registry entry for NCT00085982 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Severe Insulin Resistance appearing as the primary indexed condition, and to 1 intervention - of which Metreleptin is the first listed.
NCT00085982 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00085982 about?
NCT00085982 is a clinical study titled "Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance". Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control with conventional therapies, leading to early morbidity and mortality. We hypothesize that recombinant leptin (metreleptin) in these patients will improve glycemia control. Objectives: ...
What is the current status of trial NCT00085982?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2003-08-21. Estimated completion is 2030-01-01.
What conditions does trial NCT00085982 study?
This clinical trial studies the following conditions: Severe Insulin Resistance.
What interventions are being tested in trial NCT00085982?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT00085982?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00085982 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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