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Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

This study has been completed.
Information provided by:
Dokkyo Medical University Identifier:
First received: January 5, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Hypertension Dyslipidemia Diabetic Nephropathy Drug: pioglitazone Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Dokkyo Medical University:

Estimated Enrollment: 1000
Study Start Date: March 2004
Estimated Study Completion Date: July 2008
Detailed Description:

Primary composite endpoints:

Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)

Secondary endpoints:

urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetes HbA1c: more than 7% and less than 9%

Exclusion Criteria:

  • insulin treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00419484

Dokkyo Medical University, Koshigaya Hospital
Koshigaya, Saitama, Japan, 343-8555
Sponsors and Collaborators
Dokkyo Medical University
Principal Investigator: Yoshimasa Aso, MD Dokkyo Medical University, Koshigaya Hospital
  More Information Identifier: NCT00419484     History of Changes
Other Study ID Numbers: 0309
Study First Received: January 5, 2007
Last Updated: January 5, 2007

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Kidney Diseases
Urologic Diseases
Diabetes Complications
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 17, 2017