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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545857
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Thomas A. Wilson, Stony Brook University

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: pioglitazone Drug: Placebo control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
Study Start Date : June 2002
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Pioglitazone Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Name: Actos

Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Name: Actos

Placebo Comparator: Placebo control Drug: pioglitazone
Pioglitazone daily; dose varies with size
Other Name: Actos

Drug: Placebo control
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
Other Name: Actos




Primary Outcome Measures :
  1. C-peptide response to a Sustacal meal [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Insulin requirement [ Time Frame: 6 months ]
  2. Hemoglobin A1c [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545857


Locations
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United States, New York
Thomas A. Wilson, MD
Stony Brook, New York, United States, 11794-8111
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Thomas A Wilson, MD State University of New York Stony Brook
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas A. Wilson, Professor of Pediatrics, Stony Brook University
ClinicalTrials.gov Identifier: NCT00545857    
Other Study ID Numbers: 20064114
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012
Keywords provided by Thomas A. Wilson, Stony Brook University:
Type 1 diabetes
Insulin dependent diabetes
Juvenile onset diabetes
pioglitazone
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs