Type2 Diabetes Mellitus
Conditions
Interventions
Diet and exercise intervention
Pioglitazone (15-30 mg/day)
Sulfonylureas
Sponsors
PREVENT-J Study Steering Committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of type 2 diabetes. -Those who have received monotherapy with either diet/exercise, an a-GI, a D-phenylalanine derivative (glinide), or a biguanide. -Aged 20 or over and less than 70. -Those who have had type 2 diabetes for less than 10 years. -HbA1C of less than 7.5%. -Outpatients or inpatients. -Male or female. -Microvascular complications limited to single retinopathy, neuropathy, stage 2 nephropathy.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| -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. | — |
Countries
Japan
Contacts
Public ContactMitsuru Hashiramoto, MD
Kawasaki Medical School Department of Internal Medicine
Outcome results
None listed