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Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: March 1999


I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

Condition Intervention
Hyperinsulinism Drug: insulin-like growth factor I

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

Estimated Enrollment: 8
Study Start Date: August 1995
Estimated Study Completion Date: January 1999
Detailed Description:

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a day. The dose of IGF-I is increased each day for 4 days. Glucose is administered intravenously, when necessary, to prevent hypoglycemia.

Following the study treatment patients resume prior medication and may undergo surgery.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)
  • Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL)
  • Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia
  • No other major medical problems
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Please refer to this study by its identifier: NCT00004699

Sponsors and Collaborators
Children's Hospital of Philadelphia
Study Chair: Pinchas Cohen Children's Hospital of Philadelphia
  More Information Identifier: NCT00004699     History of Changes
Other Study ID Numbers: 199/13381
Study First Received: February 24, 2000
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
endocrine disorders
rare disease

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Complement Factor I
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors processed this record on August 22, 2017