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
1 other identifier
interventional
63
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2003
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 22, 2003
CompletedFirst Posted
Study publicly available on registry
October 23, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedJuly 11, 2014
August 1, 2011
7 months
October 22, 2003
July 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Study Arms (3)
placebo
PLACEBO COMPARATOR1.5 mL SC injection
300 mg INGAP Peptide
EXPERIMENTAL1.5 mL SC injection, once daily for 90 days
600 mg INGAP Peptide
EXPERIMENTAL1.5 mL SC injection, once daily for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Radiant Research
Irvine, California, 92618, United States
VA Hospital UCSD
San Diego, California, 92161, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, 20003, United States
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704, United States
Mercury Street Medical
Butte, Montana, 59701, United States
UNC Diabetes Care Center
Durham, North Carolina, 27713, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
University of Texas Health Science Center - Texas Diabetes Institute
San Antonio, Texas, 78207, United States
DGD Research Associates
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 22, 2003
First Posted
October 23, 2003
Study Start
October 1, 2003
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
July 11, 2014
Record last verified: 2011-08