Metact Combination Tablets special drug use surveillance Survey on long-term use for type 2 diabetes mellitus

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCT1080222318
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is appropriate 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

• Study Type: Observational
• Study Design: Not specified