Trial | NCT00071409  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ingap peptide ...

  • Study Participants

    63
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.
Study Started
Oct 31
2003
Primary Completion
May 31
2004
Study Completion
May 31
2004
Last Update
Jul 11
2014
Estimate

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

placebo Placebo Comparator

1.5 mL SC injection

300 mg INGAP Peptide Experimental

1.5 mL SC injection, once daily for 90 days

600 mg INGAP Peptide Experimental

1.5 mL SC injection, once daily for 90 days

Criteria 

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
No Results Posted