NCT00545857

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

9.9 years

First QC Date

October 16, 2007

Last Update Submit

May 30, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetesInsulin dependent diabetesJuvenile onset diabetespioglitazone

Outcome Measures

Primary Outcomes (1)

  • C-peptide response to a Sustacal meal

    6 months

Secondary Outcomes (2)

  • Insulin requirement

    6 months

  • Hemoglobin A1c

    6 months

Study Arms (2)

Pioglitazone

EXPERIMENTAL
Drug: pioglitazoneDrug: Placebo control

Placebo control

PLACEBO COMPARATOR
Drug: pioglitazoneDrug: Placebo control

Interventions

pioglitazoneDRUG

Pioglitazone daily; dose varies with size

Also known as: Actos
PioglitazonePlacebo control
Placebo controlDRUG

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

Also known as: Actos
PioglitazonePlacebo control

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with type 1 diabetes mellitus diagnosed within 4 months
  • Age \> 6 years of age
  • Ability to swallow capsule
  • Signed informed consent / assent

You may not qualify if:

  • Other illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas A. Wilson, MD

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

Location

Related Publications (1)

  • 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.

    PMID: 24379032DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas A Wilson, MD

    State University of New York Stony Brook

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

June 1, 2002

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

US(1)