NCT00071409

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Exsulin Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2003-10-23
• Last updated: 2014-07-11

Locations

10 sites across 1 country: United States