Type 2 Diabetes MellitusNCT02002975

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

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 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. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Pioglitazone
Type of treatment: Pill or oral medicine
How many people: 18,223 participants
Where: No sites listed yet
Study dates: 16 Oct 2007to 30 Jun 2013
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 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Type 2 diabetes mellitus

Who may be able to join

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

Who cannot join

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.

About this study

Official title: Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"

Read the detailed description

This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and cardiovascular events and changes in metabolic syndrome parameters, and to analyze the association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an exploratory setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20000.

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Conditions: Type 2 Diabetes Mellitus
Being tested: Pioglitazone
Keywords: Drug 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
Pioglitazone tablets

Study groups in NCT02002975
Study group	Role	What they receive
Pioglitazone 15 to 30 mg		administered orally once daily before or after breakfast for 3 years. Receives: Drug: Pioglitazone

What is being measured

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

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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Changes from baseline in HbA1c (NGSP) with number of MetS-related factor were reported instead. Risk factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, and Family History of Diabetes in Second-Degree Relatives.
Measured: 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
Measured: 3 Years

Timeline

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

16 Oct 200730 Jun 2013

First posted6 Dec 2013 (estimated)
Study start16 Oct 2007
Primary completion30 Jun 2013
Study completion30 Jun 2013

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: 18,223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002975
Sponsor's protocol ID: 237-016
Other IDs: JapicCTI-132328
Status last verified: Aug 2018
First submitted: 1 Dec 2013
Last updated: 24 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

Not yet recruitingPhase 3
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Actos Tablets Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
ClinicalTrials.gov ID: NCT02002975
Acronym / sponsor ID: 237-016
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 18,223 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 16 Oct 2007 (actual)
Primary completion: 30 Jun 2013 (actual)
Study completion: 30 Jun 2013 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 24 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

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 20000.

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast.

Study design

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

Arm	Type	Receives
Pioglitazone 15 to 30 mg	–	Drug: Pioglitazoneadministered orally once daily before or after breakfast for 3 years.

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Type 2 diabetes mellitus

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

Patients meeting any of the following criteria (1) to (5) will be excluded:
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

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: ACTOSPioglitazone tablets	Drug	Pioglitazone 15 to 30 mg

Primary outcome

Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events
Time frame: From Baseline, Up to 3 Years
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.
Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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).
Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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).
Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.
Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point
Time frame: From Baseline and final assessment point (Up to 3 Years)
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.

2 secondary outcomes

Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point
Time frame: 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
Time frame: 3 Years

Results and safety

Results posted to the registry on 24 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	18,223	17,651

Primary outcome: Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events

Time frame: From Baseline, Up to 3 Years. Number. Unit: Percentage of Participants

Measure	Pioglitazone n = 17651
Value	1.01

Population analysed: Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.

Primary outcome: Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point

Time frame: From Baseline and final assessment point (Up to 3 Years). Mean (Standard Deviation). Unit: kg

Measure	Pioglitazone n = 13653
Male Participants	1.27 (4.76)
Female Participants	1.53 (4.61)

Population analysed: Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.

Primary outcome: Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point

Time frame: From Baseline and final assessment point (Up to 3 Years). Mean (Standard Deviation). Unit: cm

Measure	Pioglitazone n = 11418
Male Participants	0.51 (5.18)
Female Participants	0.54 (6.06)

Population analysed: Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.

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

Time frame: From Baseline and final assessment point (Up to 3 Years). Mean (Standard Deviation). Unit: Percent

Measure	Pioglitazone n = 16558
Value	-1.04 (1.46)

Population analysed: Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 Years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	82 of 17,651 (0.5%)	467 of 17,651 (2.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 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
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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 2 inclusion and 7 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 24 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 24 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 Who Met at Least One New Cerebral and Cardiovascular Events (time frame: From Baseline, Up to 3 Years). The study lists 11 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 NCT02002975.

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 24 Jan 2019.