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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Insulin-Dependent
• Interventions: Drug: placebo; Drug: INGAP-Peptide

• Registration Number: NCT00071409
• Lead Sponsor: Exsulin Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-10-22
• Study First Submitted QC: 2003-10-22
• Study First Posted: 2003-10-23
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2011-08
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	1.5 mL SC injection
300 mg INGAP Peptide	INGAP-Peptide	1.5 mL SC injection, once daily for 90 days
600 mg INGAP Peptide	INGAP-Peptide	1.5 mL SC injection, once daily for 90 days

Primary Outcome Measures

Name	Time	Method
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	90 days

Trial Locations

Locations (10)

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Springfield Diabetes and Endocrine Center; 🇺🇸 Springfield, Illinois, United States

MedStar Clinical Research Center; 🇺🇸 Washington, District of Columbia, United States

VA Hospital UCSD; 🇺🇸 San Diego, California, United States

University of Texas Health Science Center - Texas Diabetes Institute; 🇺🇸 San Antonio, Texas, United States

Mercury Street Medical; 🇺🇸 Butte, Montana, United States

UNC Diabetes Care Center; 🇺🇸 Durham, North Carolina, United States

Clinical Research Institute of Southern Oregon; 🇺🇸 Medford, Oregon, United States

DGD Research Associates; 🇺🇸 San Antonio, Texas, United States

Radiant Research; 🇺🇸 Irvine, California, United States