Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

NCT ID: NCT02002975

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-16
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this survey is 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.

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 20000.

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pioglitazone 15 to 30 mg

administered orally once daily before or after breakfast for 3 years.

Pioglitazone

Intervention Type: DRUG

Pioglitazone tablets

Interventions

Pioglitazone

Pioglitazone tablets

Intervention Type: DRUG

Other Intervention Names

ACTOS

Eligibility 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, Haemoglobin A1c (HbA1c), fasting triglyceride, High-density Lipoprotein (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 pioglitazone (Actos Tablets), 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 candesartan cilexetil (Blopress) special drug use surveillance "hypertension: survey on metabolic equivalents (MetS) (Challenge-MetS)" at each medical institution.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

JapicCTI-132328

Identifier Type: REGISTRY

Identifier Source: secondary_id

237-016

Identifier Type: -

Identifier Source: org_study_id