Home
Clinical Trials
Phase II Long Term, Randomize...

Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

1999-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

OBJECTIVES:

Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00004419

Insulin Resistance Hyperglycemia

COMPLETED NA

Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance

NCT05470504

Insulin Receptor Mutation Partial Lipodystrophy

RECRUITING PHASE2

Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

NCT02533219

Hyperinsulinemic Hypoglycemia, Persistent Congenital Hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)

NO_LONGER_AVAILABLE

Leptin to Treat Severe Insulin Resistance - Pilot Study

NCT00027456

Syndrome

COMPLETED PHASE2

Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?

NCT03954873

Glucose Metabolism Disorders Endocrine or Metabolic Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.

Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperinsulinism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin-like growth factor I

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--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) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers