- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024971
Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus
Metact® Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-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.
Exclusion Criteria:
-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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pioglitazone/Metformin Hydrochloride
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
Pioglitazone/metformin hydrochloride combination tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline and Months 3, 6, 9, 12 and final assessment
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and Months 3, 6, 9, 12 and final assessment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 073-011
- JapicCTI-132368 (Registry Identifier: JapicCTI)
- JapicCTI-R150782 (Registry Identifier: JapicCTI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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