Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

May 30, 2012 updated by: Thomas A. Wilson, Stony Brook University
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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
    • New York
      • Stony Brook, New York, United States, 11794-8111
        • Thomas A. Wilson, MD

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

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 1 diabetes mellitus diagnosed within 4 months
  • Age > 6 years of age
  • Ability to swallow capsule
  • Signed informed consent / assent

Exclusion Criteria:

  • Other illnesses

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 control
Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Names:
  • Actos
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Names:
  • Actos
Experimental: Pioglitazone
Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Names:
  • Actos
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Names:
  • Actos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
C-peptide response to a Sustacal meal
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 6 months
6 months
Insulin requirement
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Thomas A Wilson, MD, State University of New York Stony Brook

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2002

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20064114

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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