Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Information source: Stony Brook University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: pioglitazone (Drug); Placebo control (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Stony Brook University Official(s) and/or principal investigator(s):
Thomas A Wilson, MD, Principal Investigator, Affiliation: State University of New York, Stony Brook
Overall contact:
Thomas A Wilson, MD, Phone: 631 444-3429, Email: Thomas.A.Wilson@SUNYSB.EDU
Summary
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes
mellitus.
Clinical Details
Official title: Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: C-peptide response to a Sustacal meal
Secondary outcome: Insulin requirementHemoglobin A1c
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
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Thomas A Wilson, MD, Phone: 631 444-3429, Email: Thomas.A.Wilson@SUNYSB.EDU
GCRC / Stony Brook University Hospital, Stony Brook, New York 11794-8111, United States; Recruiting
Thomas A Wilson, MD, Principal Investigator
Andrew H. Lane, MD, Sub-Investigator
Additional Information
Starting date: June 2002
Ending date: June 2012
Last updated: October 16, 2009
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