Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
NCT ID: NCT00071409
Last Updated: 2014-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2003-10-31
2004-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
NCT00071422
Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults
NCT00995540
A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects
NCT01638611
A Study of CT-868 in Type 1 Diabetes Mellitus
NCT06062069
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
NCT07088068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
1.5 mL SC injection
placebo
1.5 mL, once daily, self-administered SC injection for 90 days
300 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
600 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
placebo
1.5 mL, once daily, self-administered SC injection for 90 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Exsulin Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Procter and Gamble Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research
Irvine, California, United States
VA Hospital UCSD
San Diego, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, United States
Springfield Diabetes and Endocrine Center
Springfield, Illinois, United States
Mercury Street Medical
Butte, Montana, United States
UNC Diabetes Care Center
Durham, North Carolina, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
University of Texas Health Science Center - Texas Diabetes Institute
San Antonio, Texas, United States
DGD Research Associates
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2003068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.