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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071409
• Other study ID #: 2003068
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2003
• Last updated: July 10, 2014
• Start date: October 2003
• Est. completion date: May 2004

Study information

• Verified date: August 2011
• Source: Exsulin Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

Drug:
• INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
• INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
• placebo
1.5 mL, once daily, self-administered SC injection for 90 days

Locations

Country	Name	City	State
United States	Mercury Street Medical	Butte	Montana
United States	UNC Diabetes Care Center	Durham	North Carolina
United States	Radiant Research	Irvine	California
United States	Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	DGD Research Associates	San Antonio	Texas
United States	University of Texas Health Science Center - Texas Diabetes Institute	San Antonio	Texas
United States	VA Hospital UCSD	San Diego	California
United States	Springfield Diabetes and Endocrine Center	Springfield	Illinois
United States	Diablo Clinical Research	Walnut Creek	California
United States	MedStar Clinical Research Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Exsulin Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No