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Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes

This study has been completed.

Sponsored by: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00071409
  Purpose

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Drug: INGAP-Peptide
Phase II

MedlinePlus related topics:   Diabetes    Diabetes Type 1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Age 18-65
  • fasting C-peptide <0.3 ng/ml.
  • HbA1c <10%
  • Otherwise healthy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071409

Locations
United States, California
Radiant Research    
      Irvine, California, United States, 92618
Diablo Clinical Research    
      Walnut Creek, California, United States, 94598
VA Hospital UCSD    
      San Diego, California, United States, 92161
United States, District of Columbia
MedStar Clinical Research Center    
      Washington, District of Columbia, United States, 20003
United States, Illinois
Springfield Diabetes and Endocrine Center    
      Springfield, Illinois, United States, 62704
United States, Montana
Mercury Street Medical    
      Butte, Montana, United States, 59701
United States, North Carolina
UNC Diabetes Care Center    
      Durham, North Carolina, United States, 27713
United States, Oregon
Clinical Research Institute of Southern Oregon    
      Medford, Oregon, United States, 97504
United States, Texas
DGD Research Associates    
      San Antonio, Texas, United States, 78229
University of Texas Health Science Center - Texas Diabetes Institute    
      San Antonio, Texas, United States, 78207

Sponsors and Collaborators
Procter and Gamble
  More Information


Study ID Numbers:   2003068
First Received:   October 22, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00071409
Health Authority:   United States: Food and Drug Administration

Keywords provided by Procter and Gamble:
Type 1 diabetes  

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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