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

Exsulin

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Drug: INGAP-Peptide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00071409

2003068

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

1.5 mL SC injection

Treatment:

Drug: placebo

300 mg INGAP Peptide

Experimental group

Description:

1.5 mL SC injection, once daily for 90 days

Treatment:

Drug: INGAP-Peptide

Drug: INGAP-Peptide

600 mg INGAP Peptide

Experimental group

Description:

1.5 mL SC injection, once daily for 90 days

Treatment:

Drug: INGAP-Peptide

Drug: INGAP-Peptide