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

NCT02002975 | Completed Results

• 2 other identifiers: 237-016JapicCTI-132328
• Study Type: observational
• Target: 18,223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (11)

• Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events

  Cerebral and cardiovascular events (Macroangiopathy) 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. Reported data was frequency of participants who met at least one new cerebral and cardiovascular event throughout this study.

  From Baseline, Up to 3 Years

• Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in body weight as a one of metabolic syndrome parameters and for each gender (male/female).

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in waist circumference as a one of metabolic syndrome parameters and for each gender (male/female).

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HbA1c (NGSP) as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood glucose as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood insulin level as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in total cholesterol level as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HDL cholesterol level as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting triglyceride level as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in systolic blood pressure as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

• Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point

  Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in diastolic blood pressure as a one of metabolic syndrome parameters.

  From Baseline and final assessment point (Up to 3 Years)

Secondary Outcomes (2)

• Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point

  From Baseline and final assessment point (Up to 3 Years)

• Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events

  3 Years

Study Arms (1)

Pioglitazone 15 to 30 mg

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

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

Pioglitazone tablets

Also known as: ACTOS

Pioglitazone 15 to 30 mg

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2013
• First Posted: December 6, 2013
• Study Start: October 16, 2007
• Primary Completion: June 30, 2013
• Study Completion: June 30, 2013
• Last Updated: January 24, 2019
• Results First Posted: January 24, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share