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

June 23, 2005 updated by: GMP Endotherapeutics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

62

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VASDHS Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • MedStar Research Institute - Clinical Research Center
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Diabetes, Endocrinology, Metabolism Clinic
    • Texas
      • San Antonio, Texas, United States, 78284
        • Texas Diabetes Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.

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:

Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GMP Endotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Registration Dates

First Submitted

April 24, 2002

First Submitted That Met QC Criteria

April 24, 2002

First Posted (Estimate)

April 25, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INGAP-01-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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