Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024971
• Other study ID #: 073-011
• Secondary ID: JapicCTI-132368
• Status: Completed
• Phase: N/A
• First received: December 29, 2013
• Last updated: December 29, 2013
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical 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 hydrochlorie combined with metformin hydrochloride is considered suitable.

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:

1. The effects on safety and efficacy caused by changing the administration method of metformin hydrochloride associated with switching to Metact Combination Tablets

2. The effects on compliance associated with switching to Metact Combination Tablets

3. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1103
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metaformin 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.

1. Patients with cardiac insufficiency or a history of cardiac insufficiency

2. 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

3. Patients with renal impairment (including mild renal impairment)

4. Patients with hepatic impairment

5. Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus

6. Patients with severe infection, severe trauma, or pre- and post-operative patients

7. Patients who are malnourished, starved, debilitated, or have pituitary gland insufficiency or adrenal gland insufficiency

8. Patients with a history of hypersensitivity to the ingredients in Metact Combination Tablets or biguanides

9. Pregnant or potentially pregnant women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Pioglitazone/metformin hydrochloride
Pioglitazone/metformin hydrochloride combination tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse drug reactions	Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. 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.	From baseline to 12 months of treatment	Yes
Secondary	Changes 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).	From baseline to 12 months of treatment	No
Secondary	Changes 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).	From baseline to 12 months of treatment	No
Secondary	Changes 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).	From baseline to 12 months of treatment	No