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Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 143 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv143
  2. Study description revised Eligibility criteria expanded, about 3 wordsv142 Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Secondary endpoints: details revised at 2 of 2 entriesv141
  4. Results first posted: Dec 15, 2021 Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 20 to confirmed 11 · 3 morev140 Show 6 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 11
    • Primary completion date changed from estimate of Jan 1, 2030 to Oct 23, 2019
    • Secondary endpoints expanded, about 10 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  5. 4 versions Re-verified since Aug 25, 2021, no change to tracked fieldsv136-v139
Show 42 earlier versionsHide 42 earlier versions
  1. Primary endpoint revisedv135 See this version in full on ClinicalTrials.gov ↗
  2. 5 versions Re-verified since Jun 15, 2021, no change to tracked fieldsv130-v134
  3. Study description revised Study title revisedv129 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv128
  5. Eligibility criteria shortened, about 22 wordsv127 See this version in full on ClinicalTrials.gov ↗
  6. 3 versions Re-verified since Oct 30, 2020, no change to tracked fieldsv124-v126
  7. Eligibility criteria shortened, about 172 words Study description shortened, about 426 wordsv123 Show 1 more changeShow less
    • Study description shortened, about 426 words

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv122
  9. Enrollment target: 11 to 20 Trial status: Enrolling by Invitation to Recruiting · Site details revised · Publications: 6 to 4v121 Show 3 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    • Publications: 6 to 4

    See this version in full on ClinicalTrials.gov ↗

  10. 25 versions Re-verified since Aug 30, 2019, no change to tracked fieldsv96-v120
  11. Primary endpoint revised Trial status: Recruiting to Enrolling by Invitation · Enrollment target: estimated 20 to confirmed 11 · Start date: Jul 28, 2003 to Aug 21, 2003 · 2 morev95 Show 5 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Enrollment target: estimated 20 to confirmed 11
    • Start date: Jul 28, 2003 to Aug 21, 2003
    • Site details revised
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv94
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT00085982
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Severe Insulin Resistance
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov