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

An observational study of Type 2 Diabetes Mellitus, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Pioglitazone
Type of treatment: Pill or oral medicine
How many people: 246 participants
Where: No sites listed yet
Study dates: 26 Jan 2009to 30 Jun 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Type 2 diabetes mellitus

Who may be able to join

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

Who cannot join

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%)

About this study

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

Read the 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: Pioglitazone
Keywords: Pharmacological therapy
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PioglitazoneDrug
Also called Actos Tablets
Pioglitazone tablets

Study groups in NCT02181842
Study group	Role	What they receive
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). Receives: Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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 ≤.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 48 Week

Secondary outcomes (1)

Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
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.
Measured: Up to 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 200930 Jun 2011

First posted4 Jul 2014 (estimated)
Study start26 Jan 2009
Primary completion30 Jun 2011
Study completion30 Jun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02181842
Sponsor's protocol ID: 237-019
Other IDs: JapicCTI-142568
Status last verified: Jul 2018
First submitted: 2 Jul 2014
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Actos Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
ClinicalTrials.gov ID: NCT02181842
Acronym / sponsor ID: 237-019
Conditions: Type 2 Diabetes Mellitus
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 26 Jan 2009 (actual)
Primary completion: 30 Jun 2011 (actual)
Study completion: 30 Jun 2011 (actual)
First posted: 4 Jul 2014 (estimated)
Results: Posted 16 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pioglitazone	–	Drug: PioglitazonePioglitazone 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Type 2 diabetes mellitus

Key inclusion criteria (4 listed)

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:

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PioglitazoneAlso: Actos TabletsPioglitazone tablets	Drug	Pioglitazone

Primary outcome

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.
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 %.
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.
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.
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.
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.
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).
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).
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.
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 ≤.
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.
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.
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.

1 secondary outcome

Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Time frame: Up to 48 Weeks

Results and safety

Results posted to the registry on 16 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone	246	244

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

Time frame: 48 Week. Number. Unit: Percentage of Participants

Measure	Pioglitazone n = 116
Value	42.2

Population analysed: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed ' is number of participants analyzed at the given populations.

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

Time frame: 48 Week. Number. Unit: Percent age of Participants

Measure	Pioglitazone n = 115
Value	40.0

Population analysed: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here ' Number of Participants Analyzed ' is number of participants analyzed at the given populations.

Primary outcome: Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week

Time frame: From Baseline, Up to 48 Week. Mean (Standard Deviation). Unit: mmHg

Measure	Pioglitazone n = 117
Value	-6.9 (17.89)

Population analysed: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.

Primary outcome: Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week

Time frame: From Baseline, Up to 48 Week. Mean (Standard Deviation). Unit: mmHg

Measure	Pioglitazone n = 116
Value	-5 (11.96)

Population analysed: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Week 48. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	16 of 244 (6.6%)	7 of 244 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL) (time frame: 48 Week). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02181842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.