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
  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:


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
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: 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 by Stony Brook University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014