Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.

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Key information

Conditions

Diabetes Mellitus, Insulin-dependent Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Irvine, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-65
fasting C-peptide <0.3 ng/ml.
HbA1c <10%
history of onset of type 1 DM at or before 20 years of age.
Otherwise healthy

Treatment and study plan

INGAP-Peptide

Drug

1.5 mL, once daily, self-administered SC injection for 90 days

Placebo

Drug

1.5 mL, once daily, self-administered SC injection for 90 days

Primary outcomes

assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs

Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Exsulin Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Rising Dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Type I Diabetes Mellitus Patients

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Oct 23, 2003
Registry last updated: Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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