N/A
Completed N=18,223
Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Source: ClinicalTrials.gov NCT02002975 ↗Enrolled (actual)
18,223
Serious AEs
0.5%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events — 1.01 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events |
1.01 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point |
1.27; 1.53 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point |
0.51; 0.54 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point |
-1.04 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point |
-25.4 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point |
-1.58 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point |
-9.0 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point |
3.1 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point |
-28.7 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point |
-3.1 | — |
| PRIMARY Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point |
-2.8 | — |
| SECONDARY Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point |
-0.89; -1.00; -1.04; -1.04 | — |
| SECONDARY Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events |
— | — |
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:
- 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
- Patients aged < 20 or ≥ 75 years
- 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.)
- Patients who have taken pioglitazone (Actos Tablets) within 3 months before enrollment in this survey
- 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.
Data sourced from ClinicalTrials.gov (NCT02002975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.