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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment
Type 2 Diabetes Mellitus	Drug: Pioglitazone

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	18197 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Study Start Date :	October 2007
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Groups and Cohorts

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Group/Cohort	Intervention/treatment
Pioglitazone 15 to 30 mg; administered orally once daily before or after breakfast for 3 years.	Drug: Pioglitazone; Pioglitazone tablets; Other Name: ACTOS

Outcome Measures

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Primary Outcome Measures :

1. Frequency of new cerebral and cardiovascular events [ Time Frame: 3 years ]
   Cerebral and cardiovascular events include the following: - Sudden death - Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage - Acute myocardial infarction, angina pectoris requiring intervention or hospitalization for treatment - Cardiac failure requiring hospitalization for treatment - Atrial fibrillation - Aortic dissection
2. Changes in metabolic syndrome parameters [i.e., waist circumference, body weight, blood pressure, Glycosylated Hemoglobin (HbA1c), fasting triglyceride, high-density lipoprotein (HDL) cholesterol] [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events [ Time Frame: 3 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type 2 diabetes mellitus

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Takeda

Investigators

Study Chair:	Postmarketing Group Manager	Takeda

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT02002975 History of Changes
Other Study ID Numbers:	237-016; JapicCTI-132328 ( Registry Identifier: JapicCTI )
First Posted:	December 6, 2013
Last Update Posted:	December 6, 2013
Last Verified:	December 2013

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome X; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Insulin Resistance; Hyperinsulinism; Pioglitazone; Hypoglycemic Agents; Physiological Effects of Drugs