Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone

Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were 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.

Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were 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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.

Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.

Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.