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

NCT00071409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Insulin-Dependent

Interventions

DRUG

INGAP-Peptide

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

DRUG

INGAP-Peptide

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

DRUG

placebo

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

Sponsors & Collaborators

  • Exsulin Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-05-31
Completion
2004-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00071409 on ClinicalTrials.gov