Skip to main content
OpenTrials
Completed

NCT Number: NCT00545857

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas A. Wilson, MD

Stony Brook, New York, 11794-8111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

Pioglitazone daily; dose varies with size

Other names: Actos

Placebo Control

Drug

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

Other names: Actos

Primary outcomes

  1. C-peptide response to a Sustacal meal

    Time frame: 6 months

Secondary outcomes

  1. Insulin requirement

    Time frame: 6 months

  2. Hemoglobin A1c

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Important dates

Study start
2002
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2007
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.