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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pioglitazone
Placebo control
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas A. Wilson, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pioglitazone

Placebo control

Arm Description

Outcomes

Primary Outcome Measures

C-peptide response to a Sustacal meal

Secondary Outcome Measures

Insulin requirement
Hemoglobin A1c

Full Information

First Posted
October 16, 2007
Last Updated
May 30, 2012
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT00545857
Brief Title
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Official Title
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Experimental
Arm Title
Placebo control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
Pioglitazone daily; dose varies with size
Intervention Type
Drug
Intervention Name(s)
Placebo control
Other Intervention Name(s)
Actos
Intervention Description
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Primary Outcome Measure Information:
Title
C-peptide response to a Sustacal meal
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Insulin requirement
Time Frame
6 months
Title
Hemoglobin A1c
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Wilson, MD
Organizational Affiliation
State University of New York Stony Brook
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas A. Wilson, MD
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24379032
Citation
Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.
Results Reference
derived

Learn more about this trial

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

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