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

Tracking Information

First Received Date ^ICMJE

October 16, 2007

Last Updated Date

October 16, 2009

Start Date ^ICMJE

June 2002

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

C-peptide response to a Sustacal meal [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00545857 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Insulin requirement [ Time Frame: 6 months ]
Hemoglobin A1c [ Time Frame: 6 months ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

Drug: pioglitazone
Drug: Placebo control

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thomas A Wilson, MD

631 444-3429

Thomas.A.Wilson@SUNYSB.EDU

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00545857

Responsible Party

Thomas A. Wilson, State University of New York at Stony Brook

Study ID Numbers ^ICMJE

20064114

Study Sponsor ^ICMJE

Stony Brook University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas A Wilson, MD

State University of New York, Stony Brook

Information Provided By

Stony Brook University

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP