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An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets

An Open Label Study Comparing the Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets - Clinical Equivalence of Generic Pioglitazone Hydrochloride 15mg tablets (SAWAI) and ACTOS 15mg tablets

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005637
Enrollment
50
Registered
2011-05-24
Start date
2010-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic mellitus

Interventions

Continue the same oral anti-diabetic drug and the diet/exercise regimen as the preceding 20 weeks for 4 weeks. At week 0, subjects were assigned to either Generic Pioglitazone Hydrochloride 15mg (SAW

Sponsors

Tokyo-Eki Center-building Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Type 2 diabetic outpatients over 20 years of age. Treated with 15 mg daily of ACTOS tablets 15 over 20 weeks prior to week -4. Treated with single or double or triple oral hypoglycemic agent including ACTOS tablets 15 over 20 weeks prior to week -4. HbA1c <=7.0% from the data week -4. Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change From Baseline in HbA1c at Week 12

Secondary

MeasureTime frame
Change From Baseline in Fasting Plasma Glucose at Week 12

Countries

Japan

Contacts

Public ContactYasushi Fukushima

Tokyo-Eki Center-building Clinic Department of Internal Medicine

03-3517-6688

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026