Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02262806 · ClinicalTrials.gov registry record · Phase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
A Phase 2 study of Diabetes and Hyperlipidemia, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT02262806 is a Phase 2 study of Diabetes and Hyperlipidemia that is active but no longer recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 29 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02262806, a Phase 2 study of Diabetes and Hyperlipidemia, 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
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: \- To test the safety and effectiveness of metreleptin. Eligibility: * People age 6 months and older with partial lipodystrophy who * have received metreleptin through NIH studies and shown improvement AND * cannot get metreleptin other ways. Design: * Participants will come to NIH approximately every 6 months during year one, then every 1 2 years. Financial assistance may be available for travel within the U.S. * At visits, participants will get a supply of metreleptin to take home for daily injections, or it can be shipped to them inside the U.S. They will have: * plastic catheter placed in an arm vein. * blood tests, urine collection, and physical exam. * oral glucose tolerance test, drinking a sweet liquid. * ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the skin and pictures are taken of the organs. * echocardiogram, which takes pictures of the heart with sound waves. * Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they breathe is measured. * Participants will have up to 3 DEXA scan x-rays per year. * Participants may have: * annual bone x-rays. * liver biopsies every few years. A needle will be inserted into the liver to obtain a small piece. Participants will sign a separate consent for this. * Participants must be seen regularly by their local doctors and have blood tests at least every 3-6 months at home.
Conditions Studied
Interventions
- DRUG Metreleptin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-10-14 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02262806
The ClinicalTrials.gov registry entry for NCT02262806 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). 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 3 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Metreleptin is the first listed.
NCT02262806 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02262806 about?
NCT02262806 is a clinical study titled "Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy". Background: \- Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: \- To test the safety and effectiveness of ...
What is the current status of trial NCT02262806?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2014-10-14. Estimated completion is 2027-07-31.
What conditions does trial NCT02262806 study?
This clinical trial studies the following conditions: Diabetes, Hyperlipidemia, Lipodystrophy.
What interventions are being tested in trial NCT02262806?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT02262806?
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 NCT02262806 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
RECRUITING · Phase 2
-
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
RECRUITING · Phase 2
-
Biomarker Guided Therapies in Stage A/B Heart Failure
COMPLETED · Phase 2
-
Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: a Randomized Clinical Trial
COMPLETED · Phase 2
-
Effects of Human Leptin Replacement
COMPLETED · Phase 2
-
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.