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

Completed · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00034255

Run by

GMP Endotherapeutics

People needed

62

Starts

2001-12-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.
• Stage 1 and Stage 2:
• 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.
• 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.
• Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.

You may not qualify if…

• Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:
• Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
• Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
• Patients who have received any investigational product within 30 days of admission into the study.
• Patients with a history or clinical evidence of multiple organ autoimmune disorders.
• Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
• Patients who are lactating and breastfeeding.

Where it is running

• 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

Full record on ClinicalTrials.gov

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