Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus - Full Text View

Sponsor:	Stony Brook University
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00545857

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 I

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

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 ]

Estimated Enrollment:	15
Study Start Date:	June 2002
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 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

Contacts

Contact: Thomas A Wilson, MD

631 444-3429

Thomas.A.Wilson@SUNYSB.EDU

Locations

United States, New York
GCRC / Stony Brook University Hospital	Recruiting
Stony Brook, New York, United States, 11794-8111
Principal Investigator: Thomas A Wilson, MD
Sub-Investigator: Andrew H. Lane, MD

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, State University of New York at Stony Brook
ClinicalTrials.gov Identifier:	NCT00545857 History of Changes
Other Study ID Numbers:	20064114
Study First Received:	October 16, 2007
Last Updated:	August 11, 2011
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 February 12, 2012