Clinical trial NCT02002975: Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Official title: Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 18223
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus

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.

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.

Primary outcomes:
measure: Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events
timeFrame: From Baseline, Up to 3 Years
measure: Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
Secondary outcomes:
measure: Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point
timeFrame: From Baseline and final assessment point (Up to 3 Years)
measure: Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events
timeFrame: 3 Years
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: