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

This study has been completed.

First Received: October 22, 2003 Last Updated: June 23, 2005 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	2003068
Study First Received:	October 22, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00071409 History of Changes
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

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009