Type 2 Diabetes MellitusNCT02024971
Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus
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 use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride combined with metformin hydrochloride is considered… 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/metformin hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 1,103 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes mellitus
Who may be able to join
- -Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.
Who cannot join
- -Patients for whom pioglitazone hydrochloride and metformin hydrochloride are contraindicated.
- Patients with cardiac insufficiency or a history of cardiac insufficiency
- Patients with the following conditions (i) Patients with a history of lactic acidosis (ii) Dialysis patients (including peritoneal dialysis) (iii) Patients with cardiovascular conditions such as shock, cardiac insufficiency, myocardial infarction, and pulmonary embolism; patients with severely impaired pulmonary function; and patients with other conditions fostering susceptibility to hypoxemia (iv) Patients with excessive alcohol consumption (v) Patients with dehydration (vi) Patients with gastrointestinal disorders such as diarrhea and vomiting (vii) Elderly patients
- Patients with renal impairment (including mild renal impairment)
- Patients with hepatic impairment
- Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus
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- Patients with severe infection, severe trauma, or pre- and post-operative patients
- Patients who are malnourished, starved, debilitated, or have pituitary gland insufficiency or adrenal gland insufficiency
- Patients with a history of hypersensitivity to the ingredients in Metact Combination Tablets or biguanides
- Pregnant or potentially pregnant women
About this study
Official title: Metact® Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for Type 2 Diabetes Mellitus
The purpose of this study is to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride combined with metformin hydrochloride is considered suitable.
Read the detailed description
This is a special drug use surveillance (survey on long-term use) designed to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets (Metact Combination Tablets) in patients with type 2 diabetes mellitus in the routine clinical setting.
The following items will also be studied:
- The effects on safety and efficacy caused by changing the administration method of metformin hydrochloride associated with switching to Metact Combination Tablets
- The effects on compliance associated with switching to Metact Combination Tablets
- Safety and efficacy in patients who showed inadequate response to pioglitazone hydrochloride and were then switched to Metact Combination Tablets
The planned sample size was 1000 participants. The usual adult dosage is one tablet of Metact administered orally once daily after breakfast (15 mg/500 mg or 30 mg/500 mg of pioglitazone/metformin hydrochloride).
<Precautions Related to Dosage and Administration> Edema due to pioglitazone administration has been reported with comparative frequency in women. Therefore, it is preferable to be vigilant for edema and start Metact Combination Tablets at a dosage equivalent to 15 mg of pioglitazone once daily when administering the study drug to women.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone/metformin hydrochloride
- 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.
Pioglitazone/metformin hydrochlorideDrug
Also called Metact Combination Tablets
Pioglitazone/metformin hydrochloride combination tablets
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone/Metformin Hydrochloride | Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care. Receives: Drug: Pioglitazone/metformin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Drug Reactions
Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Measured: 12 months
Secondary outcomes (3)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Measured: Baseline and Months 3, 6, 9, 12 and final assessment
Change From Baseline in Fasting Blood Glucose
Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Measured: Baseline and Months 3, 6, 9, 12 and final assessment
Change From Baseline in Fasting Insulin
Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Measured: Baseline and Months 3, 6, 9, 12 and final assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJul 2010
- Primary completionNov 2013
- Study completionNov 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
- 1,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Postmarketing Group Manager, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024971
- Sponsor's protocol ID
- 073-011
- Other IDs
- JapicCTI-132368, JapicCTI-R150782
- Status last verified
- Sep 2016
- First submitted
- 29 Dec 2013
- Last updated
- 22 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metact® Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02024971
- Acronym / sponsor ID
- 073-011
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,103 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 22 Nov 2016
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 use of pioglitazone/metformin hydrochloride combination tablets in the routine clinical setting in patients with type 2 diabetes mellitus for whom therapy with pioglitazone hydrochloride combined with metformin hydrochloride is considered suitable.
Detailed description
This is a special drug use surveillance (survey on long-term use) designed to investigate the safety and efficacy of long-term use of pioglitazone/metformin hydrochloride combination tablets (Metact Combination Tablets) in patients with type 2 diabetes mellitus in the routine clinical setting.
The following items will also be studied:
- The effects on safety and efficacy caused by changing the administration method of metformin hydrochloride associated with switching to Metact Combination Tablets
- The effects on compliance associated with switching to Metact Combination Tablets
- Safety and efficacy in patients who showed inadequate response to pioglitazone hydrochloride and were then switched to Metact Combination Tablets
The planned sample size was 1000 participants. The usual adult dosage is one tablet of Metact administered orally once daily after breakfast (15 mg/500 mg or 30 mg/500 mg of pioglitazone/metformin hydrochloride).
<Precautions Related to Dosage and Administration> Edema due to pioglitazone administration has been reported with comparative frequency in women. Therefore, it is preferable to be vigilant for edema and start Metact Combination Tablets at a dosage equivalent to 15 mg of pioglitazone once daily when administering the study drug to women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone/Metformin Hydrochloride | – | Drug: Pioglitazone/metformin hydrochloridePioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes mellitus
Key inclusion criteria (1 listed)
- -Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.
Key exclusion criteria (10 listed)
- -Patients for whom pioglitazone hydrochloride and metformin hydrochloride are contraindicated.
- Patients with cardiac insufficiency or a history of cardiac insufficiency
- Patients with the following conditions (i) Patients with a history of lactic acidosis (ii) Dialysis patients (including peritoneal dialysis) (iii) Patients with cardiovascular conditions such as shock, cardiac insufficiency, myocardial infarction, and pulmonary embolism; patients with severely impaired pulmonary function; and patients with other conditions fostering susceptibility to hypoxemia (iv) Patients with excessive alcohol consumption (v) Patients with dehydration (vi) Patients with gastrointestinal disorders such as diarrhea and vomiting (vii) Elderly patients
- Patients with renal impairment (including mild renal impairment)
- Patients with hepatic impairment
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 |
|---|---|---|
| Pioglitazone/metformin hydrochlorideAlso: Metact Combination TabletsPioglitazone/metformin hydrochloride combination tablets | Drug | Pioglitazone/Metformin Hydrochloride |
Primary outcome
Number of Participants With Adverse Drug Reactions
Time frame: 12 months
Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
3 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Months 3, 6, 9, 12 and final assessment
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline and Months 3, 6, 9, 12 and final assessment
Change From Baseline in Fasting Insulin
Time frame: Baseline and Months 3, 6, 9, 12 and final assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Postmarketing Group Manager study chair
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 1 inclusion and 10 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 22 Nov 2016. 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 22 Nov 2016). 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 With Adverse Drug Reactions (time frame: 12 months). 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 22 Nov 2016.