Type 2 Diabetes Mellitus Clinical Trial
Official title:
Metact® Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for Type 2 Diabetes Mellitus
The purpose of this study is to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochlorie combined with metformin hydrochloride is considered suitable.
This is a special drug use surveillance (survey on long-term use) designed to investigate
the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination
tablets (Metact Combination Tablets) in patients with type 2 diabetes mellitus in the
routine clinical setting.
The following items will also be studied:
1. The effects on safety and efficacy caused by changing the administration method of
metformin hydrochloride associated with switching to Metact Combination Tablets
2. The effects on compliance associated with switching to Metact Combination Tablets
3. Safety and efficacy in patients who showed inadequate response to pioglitazone
hydrochloride and were then switched to Metact Combination Tablets
The planned sample size was 1000 participants. The usual adult dosage is one tablet of
Metact administered orally once daily after breakfast (15 mg/500 mg or 30 mg/500 mg of
pioglitazone/metformin hydrochloride).
<Precautions Related to Dosage and Administration> Edema due to pioglitazone administration
has been reported with comparative frequency in women. Therefore, it is preferable to be
vigilant for edema and start Metact Combination Tablets at a dosage equivalent to 15 mg of
pioglitazone once daily when administering the study drug to women.
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Observational Model: Cohort, Time Perspective: Prospective
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