Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone/metformin hydrochloride

Drug

Pioglitazone/metformin hydrochloride combination tablets

Other names: Metact Combination Tablets

Primary outcomes

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.

Secondary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Metact® Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for Type 2 Diabetes Mellitus

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Dec 31, 2013
Registry last updated: Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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