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

Sponsors

Lead Sponsor: Stony Brook University

Source Stony Brook University
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.

Overall Status Completed
Start Date June 2002
Completion Date May 2012
Primary Completion Date May 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
C-peptide response to a Sustacal meal 6 months
Secondary Outcome
Measure Time Frame
Insulin requirement 6 months
Hemoglobin A1c 6 months
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: pioglitazone

Description: Pioglitazone daily; dose varies with size

Other Name: Actos

Intervention Type: Drug

Intervention Name: Placebo control

Description: Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus

Other Name: Actos

Eligibility

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

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thomas A Wilson, MD Principal Investigator State University of New York Stony Brook
Location
Facility: Thomas A. Wilson, MD
Location Countries

United States

Verification Date

May 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stony Brook University

Investigator Full Name: Thomas A. Wilson

Investigator Title: Professor of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pioglitazone

Type: Experimental

Label: Placebo control

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov