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
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
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
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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