Type 2 diabetes mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : Actos Tablets
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational materi
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have type 2 diabetes mellitus and have undergone measurements for all of the following parameters to be included in this survey: Waist circumference, height, body weight, blood pressure, HbA1c, fasting triglyceride, HDL-cholesterol
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria (1) to (5) will be excluded: (1) Patients with any contraindications to Actos Tablets treatment as specified below: Cardiac failure, history of cardiac failure, severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, serious hepatic dysfunction, serious renal dysfunction, severe infection, perioperative state, serious trauma, history of hypersensitivity to any ingredients of Actos, pregnancy or possible pregnancy (2) Patients aged =75 years (3) Patients who currently have or have had any of the following: myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease (including left ventricular hypertrophy with reduced cardiac function*), atrial fibrillation, atrial flutter, valvular disease, aortic dissection, cerebral infarction, cerebral hemorrhage (including subarachnoid hemorrhage). (*Reduced cardiac function is roughly defined as having a brain natriuretic peptide [BNP] >=40 pg/mL.) (4) Patients who have taken Actos Tablets within 3 months before enrollment in this survey (5) Patients who have been enrolled in the Blopress special drug use surveillance "hypertension: survey on metabolic equivalents (MetS) (Challenge-MetS)" at each medical institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of new cerebral and cardiovascular events, and changes in metabolic syndrome parameters [i.e., waist circumference, body weight, blood pressure, Glycosylated Hemoglobin (HbA1c), fasting triglyceride, high-density lipoprotein (HDL)-cholesterol] Primary timeframe 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events Secondary timeframe 3 years | — |
Outcome results
None listed