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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545857
• Other study ID #: 20064114
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2007
• Last updated: May 30, 2012
• Start date: June 2002
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• pioglitazone
Pioglitazone daily; dose varies with size
• Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus

Locations

Country	Name	City	State
United States	Thomas A. Wilson, MD	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide response to a Sustacal meal		6 months	No
Secondary	Insulin requirement		6 months	No
Secondary	Hemoglobin A1c		6 months	No