Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    237-019
Previous Study | Return to List | Next Study

Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02181842
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

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

Detailed Description:

This survey was designed to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

For adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. The dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 45 mg.


Layout table for study information
Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
Actual Study Start Date : January 26, 2009
Actual Primary Completion Date : June 30, 2011
Actual Study Completion Date : June 30, 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pioglitazone
Pioglitazone 15-30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast (the dose can be adjusted; however, the maximum daily dose should not exceed 45 mg).
Drug: Pioglitazone
Pioglitazone tablets
Other Name: Actos Tablets




Primary Outcome Measures :
  1. Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) [ Time Frame: 48 Week ]
    The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level < 130 mg/dL.

  2. Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %) [ Time Frame: 48 Week ]
    The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with HbA1c (NGSP) Values < 6.9 %.

  3. Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week [ Time Frame: From Baseline, Up to 48 Week ]
    Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is SBP as a one of laboratory parameters.

  4. Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week [ Time Frame: From Baseline, Up to 48 Week ]
    Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is DBP as a one of laboratory parameters.

  5. Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week [ Time Frame: From Baseline, Up to 48 Week ]
    Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.

  6. Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week [ Time Frame: From Baseline, Up to 48 Week ]
    Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.

  7. Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone [ Time Frame: From Baseline, Up to 48 Week ]
    The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment. Mean daily dose of pioglitazone at the time of enrollment were categorized into <15 mg, 15 to <30 mg, 30 <45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).

  8. Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c [ Time Frame: From Baseline, Up to 48 Week ]
    The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment. Levels of HbA1c at the time of enrollment were categorized into <6.2%, 6.2 to <6.9%, 6.9 <7.4%, 7.4 <8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in <6.2% and 6.2 to <6.9% group).

  9. Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender [ Time Frame: From Baseline, Up to 48 Week ]
    The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment. Gender was categorized into male and female.

  10. Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI [ Time Frame: From Baseline, Up to 48 Week ]
    The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment. Levels of BMI at the time of enrollment were categorized into <18.5 kg/m^2, 18.5 to <25 kg/m^2, 25 <30 kg/m^2, and 30 kg/m^2 ≤.

  11. Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs [ Time Frame: From Baseline, Up to 48 Week ]
    The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment. Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.

  12. Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point [ Time Frame: Baseline and 48 Week ]
    Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

  13. Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point [ Time Frame: Baseline and 48 Week ]
    HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.


Secondary Outcome Measures :
  1. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) [ Time Frame: Up to 48 Weeks ]
    ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes mellitus
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients with a prior history of cerebral infarction who meet all the following conditions, [1] to [3], at the time of enrollment in the survey:

    1. First onset of cerebral infarction was at least 24 weeks prior to enrollment
    2. HbA1c values ≥ 6.5% within 12 weeks prior to the start of treatment with Pioglitazone Tablets
    3. No prior history of treatment with Pioglitazone Tablets since the first onset of cerebral infarction

Exclusion Criteria:

  • Patients who meet any of the following conditions, [1] to [5], shall be excluded from the survey:

    1. Contraindication for Actos Tablets
    2. Prior history of recurrence of cerebral infarction
    3. Prior history of cerebral hemorrhage or subarachnoid hemorrhage
    4. Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
    5. Reduced cardiac function (defined as an ejection fraction [EF] ≤ 40%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181842


Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Study Director Takeda

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02181842     History of Changes
Other Study ID Numbers: 237-019
JapicCTI-142568 ( Registry Identifier: JapicCTI )
First Posted: July 4, 2014    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: January 16, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Infarction
Diabetes Mellitus, Type 2
Cerebral Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs