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

This study has been completed.
Sponsor:
Information provided by:
Exsulin Corporation
ClinicalTrials.gov Identifier:
NCT00071409
First received: October 22, 2003
Last updated: July 10, 2014
Last verified: August 2011
  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
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Rising Dose, Multicenter Study to Evaluate the Efficacy and Safety of 90 Days of 300 or 600 mg Daily Subcutaneous Injections of INGAP Peptide in Type I Diabetes Mellitus Patients

Resource links provided by NLM:


Further study details as provided by Exsulin Corporation:

Primary Outcome Measures:
  • assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: October 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
1.5 mL SC injection
Drug: placebo
1.5 mL, once daily, self-administered SC injection for 90 days
Experimental: 300 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
Drug: INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days
Experimental: 600 mg INGAP Peptide
1.5 mL SC injection, once daily for 90 days
Drug: INGAP-Peptide
1.5 mL, once daily, self-administered SC injection for 90 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age 18-65
  • fasting C-peptide <0.3 ng/ml.
  • HbA1c <10%
  • history of onset of type 1 DM at or before 20 years of age.
  • Otherwise healthy
  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: NCT00071409

Locations
United States, California
Radiant Research
Irvine, California, United States, 92618
VA Hospital UCSD
San Diego, California, United States, 92161
Diablo Clinical Research
Walnut Creek, California, United States, 94598
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
Exsulin Corporation
  More Information

No publications provided

Responsible Party: Muhammad Rehman, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00071409     History of Changes
Other Study ID Numbers: 2003068
Study First Received: October 22, 2003
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exsulin Corporation:
Type 1 diabetes

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

ClinicalTrials.gov processed this record on November 25, 2014