Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus" - Full Text View

Purpose

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	Intervention
Type 2 Diabetes Mellitus	Drug: Pioglitazone


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:

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
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:

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


Enrollment:	18197
Study Start Date:	October 2007
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Pioglitazone 15 to 30 mg administered orally once daily before or after breakfast for 3 years.	Drug: Pioglitazone Pioglitazone tablets Other Name: ACTOS

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002975

Sponsors and Collaborators

Takeda

Investigators


Study Chair:	Postmarketing Group Manager	Takeda

More Information


Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT02002975 History of Changes
Other Study ID Numbers:	237-016 JapicCTI-132328 ( Registry Identifier: JapicCTI )
Study First Received:	December 1, 2013
Last Updated:	December 1, 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

ClinicalTrials.gov processed this record on June 22, 2017