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Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

NCT00034255•GMP Endotherapeutics

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stage 1 and Stage 2:
•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

•1. Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
•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.

Locations (4)

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

Key Dates

Start Date

December 1, 2001

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

INGAP Peptide

DRUG

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Closed Loop and Education for Hypoglycemia Awareness Restoration

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes