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

NCT02181842 | Completed Results

• 2 other identifiers: 237-019JapicCTI-142568
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (13)

• Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)

  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.

  48 Week

• Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)

  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 %.

  48 Week

• Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 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.

  From Baseline, Up to 48 Week

• Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 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.

  From Baseline, Up to 48 Week

• Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 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.

  From Baseline, Up to 48 Week

• Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 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.

  From Baseline, Up to 48 Week

• Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone

  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).

  From Baseline, Up to 48 Week

• Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c

  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).

  From Baseline, Up to 48 Week

• Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender

  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.

  From Baseline, Up to 48 Week

• Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI

  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 ≤.

  From Baseline, Up to 48 Week

• Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs

  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.

  From Baseline, Up to 48 Week

• Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point

  Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

  Baseline and 48 Week

• Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point

  HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.

  Baseline and 48 Week

Secondary Outcomes (1)

• Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)

  Up to 48 Weeks

Study Arms (1)

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

Interventions

Pioglitazone DRUG

Pioglitazone tablets

Also known as: Actos Tablets

Pioglitazone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus

You may qualify if:

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

You may not qualify if:

• Patients who meet any of the following conditions, \[1\] to \[5\], shall be excluded from the survey:
• Contraindication for Actos Tablets
• Prior history of recurrence of cerebral infarction
• Prior history of cerebral hemorrhage or subarachnoid hemorrhage
• Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease
• Reduced cardiac function (defined as an ejection fraction \[EF\] ≤ 40%)

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: July 2, 2014
• First Posted: July 4, 2014
• Study Start: January 26, 2009
• Primary Completion: June 30, 2011
• Study Completion: June 30, 2011
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share