Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Pioglitazone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Postmarketing Group Manager, Study Chair, Affiliation: Takeda
Summary
This study is designed to determine the onset of new cerebral and cardiovascular events and
changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus on
long-term pioglitazone (Actos Tablets) treatment.
Clinical Details
Official title: Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Frequency of new cerebral and cardiovascular eventsChanges in metabolic syndrome parameters [i.e., waist circumference, body weight, blood pressure, Glycosylated Hemoglobin (HbA1c), fasting triglyceride, high-density lipoprotein (HDL) cholesterol]
Secondary outcome: Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events
Detailed description:
This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in
patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and
cardiovascular events and changes in metabolic syndrome parameters, and to analyze the
association between patient baseline characteristics, including any metabolic
syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an
exploratory setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is
20,000.
The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before
or after breakfast.
Eligibility
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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:
- Patients meeting any of the following criteria (1) to (5) will be excluded:
1. Patients with any contraindications to pioglitazone (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 < 20 or ≥ 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 cardiac hypofunction*), 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 pioglitazone (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.
Locations and Contacts
Additional Information
Starting date: October 2007
Last updated: December 1, 2013
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