Safety and Efficacy of INGAP-Peptide in Patients With Type 2 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 Insulin-using Type 2 Diabetes Mellitus Patients
1 other identifier
interventional
126
1 country
17
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 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. 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 improve the ability to produce insulin in type 2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2003
Shorter than P25 for phase_2
17 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
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedJuly 11, 2014
August 1, 2011
8 months
October 22, 2003
July 10, 2014
Conditions
Keywords
Study Arms (3)
placebo
PLACEBO COMPARATOR1.5 mL SC injection, once daily for 90 days
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 35-70
- Using \>20 Units of insulin per day
- HbA1c from 6.5% to 10%
- No islet antibodies
- Otherwise healthy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Diabetes and Endocrine Associates
La Jolla, California, 92037, United States
VA Hospital UCSD
San Diego, California, 92161, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Unknown Facility
Denver, Colorado, 80209, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, 20003, United States
Future Care Studies
Springfield, Massachusetts, 01107, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Diabetes-Endocrinology Center of WNY
Buffalo, New York, 14209, United States
UNC Diabetes Care Center
Durham, North Carolina, 27713, United States
Piedmont Medical Group
Winston-Salem, North Carolina, 27103, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
Mountain View Clinical Research
Greer, South Carolina, 29651, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, 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
Charlottesville Medical Research
Charlottesville, Virginia, 22911, 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
June 1, 2004
Study Completion
June 1, 2004
Last Updated
July 11, 2014
Record last verified: 2011-08