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

This study has been completed.
Sponsor:
Information provided by:
GMP Endotherapeutics
ClinicalTrials.gov Identifier:
NCT00034255
First received: April 24, 2002
Last updated: June 23, 2005
Last verified: June 2003
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: INGAP Peptide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients

Resource links provided by NLM:


Further study details as provided by GMP Endotherapeutics:

Estimated Enrollment: 62
Study Start Date: December 2001
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034255

Locations
United States, California
VASDHS Medical Center
San Diego, California, United States, 92161
United States, District of Columbia
MedStar Research Institute - Clinical Research Center
Washington, District of Columbia, United States, 20003
United States, North Carolina
UNC Diabetes, Endocrinology, Metabolism Clinic
Durham, North Carolina, United States, 27713
United States, Texas
Texas Diabetes Institute
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
GMP Endotherapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034255     History of Changes
Other Study ID Numbers: INGAP-01-001
Study First Received: April 24, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014