NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000947

Registered date:14/12/2007

Reversal of diabetes and prevention of arteriosclerosis in type 2 diabetic patients with oral antidiabetic agents

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType2 Diabetes Mellitus
Date of first enrollment2007/12/01
Target sample size500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Diet and exercise intervention Pioglitazone (15-30 mg/day) Sulfonylureas

Outcome(s)

Primary Outcome-Duration of the period during which the patients's HbA1c level continued to be less thna 7.0% after completion of dosing (i.e. the observation period of 1.5 yrs) (Kaplan-Meier method). -Duration of dosing (i.e. during the 1.5 years after registration) in which the patient's HbA1c level continued to be less than 7.5% (Kaplan-Meier method). -Indices for atherosclerosis: hsCRP, urinary 8-OHdG, and adiponectin.
Secondary Outcome-Proportion of patients who achieved an HbA1c level of less than 6.5% after 1.5 years of dosing (Kaplan-Meier method). -Duration of the period in which the patient's HbA1c levels continued to be less than 5.8% (Kaplan-Meier method). -Cardiovascular events (Kaplan-Meier method) -Urinary microalbumin (adjusted for creatinine) -Insulin and proinsulin -Changes in lipids: TC, TG, HDL-C, LDL-C -Changes in blood pressure -Changes in liver tests: ALT, AST, g-GTP, and LDH). Safety: edema, hypoglycemia, and others.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria-Heart failure or history of heart failure. -EF of less than 40%. -History of adverse reactions to a thiazolidine derivative or concerns about safety. -Severe hepatic dysfunction. -Severe renal dysfunction. -History of cardiovascular disease. -Current treatment with a sulfonylurea drug. -Current treatment with a thiazolidine derivative. -Current treatment with insulin. -Those whom the principle investigator or other investigators consider unsuitable.

Related Information

Contact

public contact
Name Mitsuru Hashiramoto, MD
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan. Japan
Telephone 086-464-1046
E-mail hashira@med.kawasaki-m.ac.jp
Affiliation Kawasaki Medical School Department of Internal Medicine
scientific contact
Name Kouhei Kaku, MD
Address 577 Matsushima, Kurashiki, Okayama 701-0192, Japan. Japan
Telephone 086-464-1046
E-mail
Affiliation Kawasaki Medical School Department of Internal Medicine