Additional effects of pioglitazone on type 2 diabetes who were inappropriately controled with

UMIN ID: UMIN000002333

Registered date:15/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2007/07/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The patients were randomly divided into 2 groups (oral pioglitazone titrated from 15 mg to 30 mg or no pioglitazone, to be taken in addition to their glucose-lowering drugs and other medications) matched for age, gender, BMI, and baseline HbA1C after screen through the use of a computer-generated random number sequence. Patients were given recommendations for diet therapy during screening period and after randomization. No restriction was imposed on patients taking any oral diabetic agent except thiazolidinediones for control group and other oral drugs such as blood pressure-lowering and lipid-lowering drugs, and the dosage of the insulin and drugs can be changed freely by the physician's decision during the study.
any drugs other than pioglitazone are allowed to be used.

Outcome(s)

• Primary Outcome: 1.HbA1C as glycemic control 2.Total daily dose and number of insulin 3.change of IMT
• Secondary Outcome: frequency of hypoglycemic attack

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.the patients who had CVD or appoplexy within 6 months 2. the patients who have had hear failure (NYHA >III) 3. severe hepatic or renal failure 4. the patients who have had diabetic ketoacidosis 5. pregnant women 6. the pateints who has history of severe adverse effects with pioglitazone

Related Information

• Primary Sponsor: Department of Medicine, Metabolism and Endocrinology Juntendo University School of Medicine
• Source(s) of Monetary Support: Takeda Pharmaceutical Industory