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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas A. Wilson, Stony Brook University
ClinicalTrials.gov Identifier:
NCT00545857
First received: October 16, 2007
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: pioglitazone
Drug: Placebo control
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • C-peptide response to a Sustacal meal [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin requirement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2002
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Name: Actos
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Name: Actos
Placebo Comparator: Placebo control Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Name: Actos
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Name: Actos

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545857

Locations
United States, New York
Thomas A. Wilson, MD
Stony Brook, New York, United States, 11794-8111
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Thomas A Wilson, MD State University of New York, Stony Brook
  More Information

No publications provided

Responsible Party: Thomas A. Wilson, Professor of Pediatrics, Stony Brook University
ClinicalTrials.gov Identifier: NCT00545857     History of Changes
Other Study ID Numbers: 20064114
Study First Received: October 16, 2007
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Type 1 diabetes
Insulin dependent diabetes
Juvenile onset diabetes
pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012