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

Stony Brook University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

pioglitazoneDRUG

Pioglitazone daily; dose varies with size

Placebo controlDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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 (1)

Thomas A. Wilson, MD

Stony Brook, New York, United States

Outcomes

Primary Outcomes

C-peptide response to a Sustacal meal

Time frame: 6 months

Secondary Outcomes

Insulin requirement

Time frame: 6 months

Hemoglobin A1c

Time frame: 6 months

Data from ClinicalTrials.gov

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