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Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
This study has been completed.
Sponsored by: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00071422
  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 2 diabetes is a disease where the beta cells are unable to meet a person's insulin needs. 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 improve the ability to produce insulin in type 2 diabetic patients.


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

MedlinePlus related topics: Diabetes
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:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Age 35-70
  • Using >20 Units of insulin per day
  • HbA1c from 6.5% to 10%
  • No islet antibodies
  • Otherwise healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071422

Locations
United States, California
Diabetes and Endocrine Associates
La Jolla, California, United States, 92037
Diablo Clinical Research
Walnut Creek, California, United States, 94598
VA Hospital UCSD
San Diego, California, United States, 92161
United States, Colorado
Longmont Medical Research Network
Longmont, Colorado, United States, 80501
Denver, Colorado, United States, 80209
United States, District of Columbia
MedStar Clinical Research Center
Washington, District of Columbia, United States, 20003
United States, Massachusetts
Future Care Studies
Springfield, Massachusetts, United States, 01107
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, New York
Diabetes-Endocrinology Center of WNY
Buffalo, New York, United States, 14209
United States, North Carolina
Piedmont Medical Group
Winston Salem, North Carolina, United States, 27103
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, South Carolina
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
United States, Texas
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230
DGD Research Associates
San Antonio, Texas, United States, 78229
University of Texas Health Science Center - Texas Diabetes Institute
San Antonio, Texas, United States, 78207
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Procter and Gamble
  More Information

Study ID Numbers: 2003069
Study First Received: October 22, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00071422  
Health Authority: United States: Food and Drug Administration

Keywords provided by Procter and Gamble:
Type 2 diabetes

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009