Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
NCT ID: NCT00034255
Last Updated: 2005-06-24
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
PHASE1/PHASE2
62 participants
INTERVENTIONAL
2001-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INGAP Peptide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.
2. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.
3. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.
Exclusion Criteria
2. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
3. Patients who have received any investigational product within 30 days of admission into the study.
4. Patients with a history or clinical evidence of multiple organ autoimmune disorders.
5. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
6. Patients who are lactating and breastfeeding.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GMP Endotherapeutics
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VASDHS Medical Center
San Diego, California, United States
MedStar Research Institute - Clinical Research Center
Washington D.C., District of Columbia, United States
UNC Diabetes, Endocrinology, Metabolism Clinic
Durham, North Carolina, United States
Texas Diabetes Institute
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.
INGAP-01-001
Identifier Type: -
Identifier Source: org_study_id