Type 2 Diabetes MellitusNCT02068508
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
An observational study of Type 2 Diabetes Mellitus, run by Takeda.
Trial summary
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet… 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
- 1,067 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2009to 30 Jun 2014
- 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
- Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.
- Participants treated with an insulin product for at least 4 weeks
- Participants who started Actos Tablets for the first time after the start of an insulin product
- Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Who cannot join
- Participants with contraindications to Actos Tables and insulin products treatment
About this study
Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.
Read the detailed description
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.
- 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 group | Role | What they receive |
|---|---|---|
| Pioglitazone | Pioglitazone 15 mg to 30 mg, orally, once daily Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Week 52
Secondary outcomes (6)
Change From Baseline in Fasting Blood Glucose
Measured: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Fasting Triglycerides
Measured: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in HDL Cholesterol
Measured: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in LDL Cholesterol
Measured: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points
Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points.
Measured: Baseline, Week 52, and final assessment (up to Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study start30 Jul 2009
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
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
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068508
- Sponsor's protocol ID
- 237-018
- Other IDs
- JapicCTI-132376, JapicCTI-R171012
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2014
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actos Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"
- ClinicalTrials.gov ID
- NCT02068508
- Acronym / sponsor ID
- 237-018
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2009 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.
Detailed description
This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | – | Drug: PioglitazonePioglitazone 15 mg to 30 mg, orally, once daily |
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)
- Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.
- Participants treated with an insulin product for at least 4 weeks
- Participants who started Actos Tablets for the first time after the start of an insulin product
- Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets
Key exclusion criteria (1 listed)
- Participants with contraindications to Actos Tables and insulin products treatment
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 |
Primary outcome
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Time frame: Up to Week 52
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.
6 secondary outcomes
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in Fasting Triglycerides
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in HDL Cholesterol
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Change From Baseline in LDL Cholesterol
Time frame: Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)
Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points
Time frame: Baseline, Week 52, and final assessment (up to Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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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 1 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 12 Mar 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 18 Feb 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?
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.