An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets
Not Applicable
- Conditions
- Type 2 diabetic mellitus
- Registration Number
- JPRN-UMIN000005637
- Lead Sponsor
- Tokyo-Eki Center-building Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
History and/or complication of cardiac failure. Need of insulin therapy. Treated using three or more oral anti-diabetes drugs other than ACTOS tablets 15. Renal or liver dysfunction. Complication with or recent history of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction. Malignant neoplasms. Severe ketosis, diabetic coma. History of hypersensitive reaction to pioglitazone. History of major gastrointestinal surgery. Pregnancy. History of alcohol abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose at Week 12