Back to resultsSafety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Insulin-Dependent
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INGAP-Peptide
INGAP-Peptide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent focused on measuring Type 1 diabetes
Eligibility 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
Sites / Locations
- Radiant Research
- VA Hospital UCSD
- Diablo Clinical Research
- MedStar Clinical Research Center
- Springfield Diabetes and Endocrine Center
- Mercury Street Medical
- UNC Diabetes Care Center
- Clinical Research Institute of Southern Oregon
- University of Texas Health Science Center - Texas Diabetes Institute
- DGD Research Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
placebo
300 mg INGAP Peptide
600 mg INGAP Peptide
Arm Description
1.5 mL SC injection
1.5 mL SC injection, once daily for 90 days
1.5 mL SC injection, once daily for 90 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00071409
Brief Title
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Exsulin Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Insulin-Dependent
Keywords
Type 1 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1.5 mL SC injection
Arm Title
300 mg INGAP Peptide
Arm Type
Experimental
Arm Description
1.5 mL SC injection, once daily for 90 days
Arm Title
600 mg INGAP Peptide
Arm Type
Experimental
Arm Description
1.5 mL SC injection, once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
INGAP-Peptide
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days
Intervention Type
Drug
Intervention Name(s)
INGAP-Peptide
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1.5 mL, once daily, self-administered SC injection for 90 days
Primary Outcome Measure Information:
Title
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
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Radiant Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
VA Hospital UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
MedStar Clinical Research Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Springfield Diabetes and Endocrine Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
UNC Diabetes Care Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
University of Texas Health Science Center - Texas Diabetes Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
DGD Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
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