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

This study has been completed.
Sponsor:
Information provided by:
Dokkyo Medical University
ClinicalTrials.gov Identifier:
NCT00419484
First received: January 5, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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
Time Perspective: Longitudinal

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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations
Japan
Dokkyo Medical University, Koshigaya Hospital
Koshigaya, Saitama, Japan, 343-8555
Sponsors and Collaborators
Dokkyo Medical University
Investigators
Principal Investigator: Yoshimasa Aso, MD Dokkyo Medical University, Koshigaya Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00419484     History of Changes
Other Study ID Numbers: 0309
Study First Received: January 5, 2007
Last Updated: January 5, 2007
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Hypertension
Kidney Diseases
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014