Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events
- Conditions
- Type2 Diabetes
- Registration Number
- JPRN-UMIN000001363
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 550
Not provided
(1)Subjects who were diagnosed with type 1 diabetes mellitus (2)Subjects with a BMI of <22 and a fasting IRI of <5 mU/mL (3)Subjects who required insulin therapy to control the blood glucose of diabetes mellitus, or who were on insulin therapy (4)Subjects with a history of hepatic function disorder due to the use of thiazolidinediones (e.g., troglitazone and pioglitazone) (5)Subjects currently on pioglitazone therapy (6)Subjects who had cardiac failure or a history thereof (7)Subjects with cardiovascular disorders (those who met the following conditions) 1)Subjects with onset of myocardial infarction within 6 months 2)Subjects who received hospital treatment for acute coronary syndrome within 3 months 3) Subjects who underwent coronary artery bypass surgery or percutaneous transluminal coronary angioplasty within 6 months (8)Subjects with the complication of severe arrhythmia (9)Subjects with cerebrovasculardisorders [those with onset of cerebrovascular disorder (excluding TIA)] (10)Subjects who needed management of their blood glucose by insulin injection, due to severe infection, before or after operation, or serious traumatic injury (11)Subjects with scheduled coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, or surgery for leg ischemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method