NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	10/06/2014
Target sample size	500
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : Actos Tablets (pioglitazone) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : For adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. The dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 45 mg.

Outcome(s)

Primary Outcome

Status of glycemic control Primary timeframe: From baseline to 48 weeks of treatment The following variables will be tabulated and analyzed: [1] Changes from baseline in laboratory parameters [2] Changes from baseline in laboratory parameters characteristics at the time of enrollment [3] Change from baseline in the rate of patients achieving good glycemic control (i.e., HbA1c values < 6.5%) [4] Blood glucose-related laboratory parameters at each time point

Secondary Outcome

Adverse events Secondary timeframe: For 48 weeks The frequencies of all adverse events observed during the observation period will be tabulated by symptom, type, and seriousness. In addition, the frequency of recurrence of cerebral infarction will be tabulated by time from first onset of cerebral infarction, risk factors for cerebral infarction, concomitant antihypertensive medications (if any), and concomitant antiplatelet/anticoagulant medications (if any). Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of pioglitazone whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with pioglitazone are defined as adverse drug reactions.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, [1] to [3], at the time of enrollment in the survey: [1] First onset of cerebral infarction was at least 24 weeks prior to enrollment [2] HbA1c values >= 6.5% within 12 weeks prior to the start of treatment with Actos Tablets [3] No prior history of treatment with Actos Tablets since the first onset of cerebral infarction
Exclude criteria	Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey: [1] Contraindication for Actos Tablets [2] Prior history of recurrence of cerebral infarction [3] Prior history of cerebral hemorrhage or subarachnoid hemorrhage [4] Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease [5] Reduced cardiac function (defined as an ejection fraction [EF] <= 40%)