Effect of Pioglitazone on the Course of New Onset Type 1... | NCT00545857

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

NCT00545857

Sponsor

Stony Brook University

Status

Completed

Last Update Posted

May 31, 2012Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Type 1 Diabetes Mellitus

Interventions

pioglitazone
Placebo control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Oct 16, 2007

First Submission Date that Met QC Criteria

Oct 16, 2007

First Posted Date

Oct 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2012

Last Update Posted Date

May 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pioglitazone	Experimental		Drug: pioglitazone Drug: Placebo control
Placebo control	Placebo Comparator		Drug: pioglitazone Drug: Placebo control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pioglitazone	Drug	Pioglitazone daily; dose varies with size	Pioglitazone Placebo control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
C-peptide response to a Sustacal meal		6 months

Secondary Outcomes

Measure	Description	Time Frame
Insulin requirement		6 months
Hemoglobin A1c		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas A Wilson, MD	State University of New York Stony Brook	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas A. Wilson, MD		Stony Brook	New York	11794-8111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24379032	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals