Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, June 1999

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Beth Israel Deaconess Medical Center
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004419

Purpose

OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion, hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have failed other therapies.

II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary abnormalities in this patient population.

III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like growth factor binding protein 1, the regulation of sex hormone binding globulin, and hypothalamic pituitary gonadal axis in this patient population.

Condition	Intervention
Insulin Resistance Hyperglycemia	Drug: insulin-like growth factor I

Drug Information available for: Insulin Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	18
Study Start Date:	April 1998

Detailed Description:

PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.

Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19 of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the clinical center for repeat screening tests. Patients then receive maintenance therapy of rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase. Patients are followed weekly, biweekly, or monthly depending on blood glucose response of patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory during this time.

Eligibility

Ages Eligible for Study:	14 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Hematologically proven severe insulin resistance with or without diabetes
Fasting insulin greater than 40 U/mL
Post glucose insulin greater than 300 U/mL (unless overt diabetes mellitus is present)

--Prior/Concurrent Therapy--

Endocrine therapy: No concurrent oral hypoglycemic agents and/or insulin

Other: No concurrent birth control pills

--Patient Characteristics--

Not pregnant
Negative pregnancy test
Effective barrier contraceptive method must be used by fertile patients
Good health

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004419

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alan C. Moses 617-667-4269

Sponsors and Collaborators

FDA Office of Orphan Products Development

Beth Israel Deaconess Medical Center

Investigators

Study Chair:

Alan C. Moses

Beth Israel Deaconess Medical Center

More Information

No publications provided

Study ID Numbers:	199/13313, BIH-98-1060, BIH-E-147, BIH-FDR001126
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004419 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

endocrine disorders
insulin resistance
rare disease

Study placed in the following topic categories:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Rare Diseases
Mitogens

Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Mitosis Modulators
Mitogens
Insulin Resistance
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009