|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus |
| 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 |
|---|---|
| Pioglitazone: Experimental |
Drug: pioglitazone
Pioglitazone daily; dose varies with size
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
|
| Placebo control: Placebo Comparator |
Drug: pioglitazone
Pioglitazone daily; dose varies with size
Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of 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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas A Wilson, MD | 631 444-3429 | Thomas.A.Wilson@SUNYSB.EDU |
| 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 | |
| Principal Investigator: | Thomas A Wilson, MD | State University of New York, Stony Brook |
More Information
| Responsible Party: | State University of New York at Stony Brook ( Thomas A. Wilson ) |
| Study ID Numbers: | 20064114 |
| Study First Received: | October 16, 2007 |
| Last Updated: | October 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00545857 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Type 1 diabetes Insulin dependent diabetes Juvenile onset diabetes pioglitazone |
|
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Pioglitazone Immune System Diseases Diabetes Mellitus, Type 1 |
Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |