Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085982
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2004-06-18
Brief Title:
Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Trial of Effect of Metreleptin Therapy in Severe Insulin Resistance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 insulinC-peptide glucoseinsulinC-peptide area under the curve during oral glucose tolerance test
Study Population
20 male or female patients with mutations of the insulin receptor age Bullet5 years at the NIH Clinical Center
Description of SitesFacilities Enrolling Participants Description of Study Intervention
NIH Clinical Center
Open label study of metreleptin 02 mgkgday max dose 024 mgkgday
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 insulinC-peptide glucoseinsulinC-peptide area under the curve during oral glucose tolerance test
Study Population
20 male or female patients with mutations of the insulin receptor age Bullet5 years at the NIH Clinical Center
Description of SitesFacilities Enrolling Participants Description of Study Intervention
NIH Clinical Center
Open label study of metreleptin 02 mgkgday max dose 024 mgkgday
Detailed Description:
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 insulinC-peptide glucoseinsulinC-peptide area under the curve during oral glucose tolerance test
Study Population
20 male or female patients with mutations of the insulin receptor age Bullet5 years at the NIH Clinical Center
Description of SitesFacilities Enrolling Participants Description of Study Intervention
NIH Clinical Center
Open label study of metreleptin 02 mgkgday max dose 024 mgkgday
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 insulinC-peptide glucoseinsulinC-peptide area under the curve during oral glucose tolerance test
Study Population
20 male or female patients with mutations of the insulin receptor age Bullet5 years at the NIH Clinical Center
Description of SitesFacilities Enrolling Participants Description of Study Intervention
NIH Clinical Center
Open label study of metreleptin 02 mgkgday max dose 024 mgkgday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-DK-0257 | None | None | None |