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

July 10, 2014 updated by: Exsulin Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exsulin Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

October 22, 2003

First Submitted That Met QC Criteria

October 22, 2003

First Posted (Estimate)

October 23, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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