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

Sponsor
GMP Endotherapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00034255
Collaborator
(none)
62
Enrollment
4
Locations
15.5
Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: INGAP Peptide
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Study Start Date :
Dec 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VASDHS Medical Center San Diego California United States 92161
    2 MedStar Research Institute - Clinical Research Center Washington District of Columbia United States 20003
    3 UNC Diabetes, Endocrinology, Metabolism Clinic Durham North Carolina United States 27713
    4 Texas Diabetes Institute San Antonio Texas United States 78284

    Sponsors and Collaborators

    • GMP Endotherapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00034255
    Other Study ID Numbers:
    • INGAP-01-001
    First Posted:
    Apr 25, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 2003
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jun 24, 2005