NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	04/12/2013
Target sample size	1000
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Metact Combination Tablets (pioglitazone/metformin hydrochloride) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 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 Metact to women.

Outcome(s)

Primary Outcome

Frequency of adverse drug reactions Primary timeframe From baseline to 12 months of treatment Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

Secondary Outcome

Changes in HbA1c and clinical laboratory values (fasting blood glucose and fasting insulin) Secondary timeframe From baseline to 12 months of treatment 1. Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline-test value at baseline). 2. Tabulation of the fasting blood glucose and fasting insulin test values and change at each test time point (test value at each test time point after baseline-test value at baseline).

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is appropriate and for whom long-term treatment with Metact Combination Tablets is considered necessary.
Exclude criteria	Patients for whom pioglitazone hydrochloride and metformin hydrochloride are contraindicated. (1) Patients with cardiac insufficiency or a history of cardiac insufficiency (2) Patients with the following conditions (i) Patients with a history of lactic acidosis (ii) Dialysis patients (including peritoneal dialysis) (iii) Patients with cardiovascular conditions such as shock, cardiac insufficiency, myocardial infarction, and pulmonary embolism; patients with severely impaired pulmonary function; and patients with other conditions fostering susceptibility to hypoxemia (iv) Patients with excessive alcohol consumption (v) Patients with dehydration (vi) Patients with gastrointestinal disorders such as diarrhea and vomiting (vii) Elderly patients (3) Patients with renal impairment (including mild renal impairment) (4) Patients with hepatic impairment (5) Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus (6) Patients with severe infection, severe trauma, or pre- and post-operative patients (7) Patients who are malnourished, starved, debilitated, or have pituitary gland insufficiency or adrenal gland insufficiency (8) Patients with a history of hypersensitivity to the ingredients in Metact Combination Tablets or biguanides (9) Pregnant or potentially pregnant women