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Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
This study is currently recruiting participants.
Study NCT00545857   Information provided by Stony Brook University
First Received: October 16, 2007   Last Updated: October 16, 2009   History of Changes

October 16, 2007
October 16, 2009
June 2002
C-peptide response to a Sustacal meal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
C-peptide response to a Sustacal meal [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00545857 on ClinicalTrials.gov Archive Site
  • Insulin requirement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Insulin requirement [ Time Frame: 6 months ]
  • Hemoglobin A1c [ Time Frame: 6 months ]
 
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

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

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.

Phase I
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Type 1 Diabetes Mellitus
  • Drug: pioglitazone
  • Drug: Placebo control
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
15
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact: Thomas A Wilson, MD 631 444-3429 Thomas.A.Wilson@SUNYSB.EDU
United States
 
NCT00545857
Thomas A. Wilson, State University of New York at Stony Brook
20064114
Stony Brook University
 
Principal Investigator: Thomas A Wilson, MD State University of New York, Stony Brook
Stony Brook University
April 2009

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