Safety and Efficacy of INGAP-Peptide in Patients With Type 2 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 Insulin-using Type 2 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

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
      • La Jolla, California, United States, 92037
        • Diabetes and Endocrine Associates
      • San Diego, California, United States, 92161
        • VA Hospital UCSD
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80209
      • Longmont, Colorado, United States, 80501
        • Longmont Medical Research Network
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • MedStar Clinical Research Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Future Care Studies
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • New York
      • Buffalo, New York, United States, 14209
        • Diabetes-Endocrinology Center of WNY
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Diabetes Care Center
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Group
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Center
      • San Antonio, Texas, United States, 78207
        • University of Texas Health Science Center - Texas Diabetes Institute
      • San Antonio, Texas, United States, 78229
        • DGD Research Associates
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age 35-70
  • Using >20 Units of insulin per day
  • HbA1c from 6.5% to 10%
  • No islet antibodies
  • 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
1.5 mL SC injection, once daily for 90 days
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

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)

June 1, 2004

Study Completion (ACTUAL)

June 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

  • 2003069

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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