An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

Lipodystrophy Clinical Trial

Official title:

An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677313
• Other study ID #: MB002-002
• Secondary ID: FHA101
• Status: Completed
• Phase: N/A
• First received: May 12, 2008
• Last updated: April 8, 2015
• Start date: March 2009
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investigators with respect to identification of appropriate subjects for metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy data following metreleptin treatment in this population

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Is male or female =5 years old

• If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

1. Not breastfeeding

2. Negative pregnancy test result

3. Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)

• Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation

• Has been diagnosed with at least one of the following 2 metabolic disorders:

1. Diabetes Mellitus

2. Hypertriglyceridemia as defined by fasting triglyceride concentrations >200 mg/dL

• If =18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements

• If <18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child.

Exclusion Criteria:

• Has been diagnosed with HIV infection

• Has known infectious liver disease

• Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertriglyceridemia
• Lipodystrophy

Intervention

Drug:
• metreleptin
metreleptin injection

Locations

Country	Name	City	State
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Chicago	Illinois
United States	Research Site	Greenville	North Carolina
United States	Local Institution	Reno	Nevada
United States	Research Site	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide metreleptin, an investigational medication, under a treatment protocol to subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia		open ended
Secondary	To monitor the safety and tolerability of metreleptin in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia		open ended
Secondary	Information on the efficacy of metreleptin as assessed by its effects on fasting triglyceride concentrations, HbA1c, and fasting glucose concentrations in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia		open ended

External Links

•   BMS Clinical Trials Disclosure
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form