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

• Sponsor: Exsulin Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00071409
• Collaborator: (none)
• Enrollment: 63
• Locations: 10
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Drug: INGAP-Peptide; Drug: INGAP-Peptide; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo 1.5 mL SC injection	Drug: placebo; 1.5 mL, once daily, self-administered SC injection for 90 days
Experimental: 300 mg INGAP Peptide 1.5 mL SC injection, once daily for 90 days	Drug: INGAP-Peptide; 1.5 mL, once daily, self-administered SC injection for 90 days
Experimental: 600 mg INGAP Peptide 1.5 mL SC injection, once daily for 90 days	Drug: INGAP-Peptide; 1.5 mL, once daily, self-administered SC injection for 90 days

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Irvine	California	United States	92618
2	VA Hospital UCSD	San Diego	California	United States	92161
3	Diablo Clinical Research	Walnut Creek	California	United States	94598
4	MedStar Clinical Research Center	Washington	District of Columbia	United States	20003
5	Springfield Diabetes and Endocrine Center	Springfield	Illinois	United States	62704
6	Mercury Street Medical	Butte	Montana	United States	59701
7	UNC Diabetes Care Center	Durham	North Carolina	United States	27713
8	Clinical Research Institute of Southern Oregon	Medford	Oregon	United States	97504
9	University of Texas Health Science Center - Texas Diabetes Institute	San Antonio	Texas	United States	78207
10	DGD Research Associates	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Exsulin Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00071409
• Other Study ID Numbers: 2003068
• First Posted: Oct 23, 2003
• Last Update Posted: Jul 11, 2014
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: Type 1 diabetes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 11, 2014