Sonias Combination Tablets special drug use surveillance Survey on long-term use in type 2 diabetes mellitus
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080222388
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1000
Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary
(1) Patients with cardiac failure or a history of cardiac failure
(2) Patients with serious hepatic or renal impairment
(3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
(4) Patients with severe infection, severe trauma, or pre- and post-operative patients
(5) Patients with gastrointestinal disorders such as diarrhea and vomiting
(6) Pregnant or potentially pregnant women
(7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse drug reactions<br>Primary timeframe For 12 months<br>The frequency of adverse drug reactions by type, seriousness, time to onset 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 the study drug are defined as adverse drug reactions.
- Secondary Outcome Measures
Name Time Method Changes from baseline in diabetes-related test values<br>Secondary timeframe Baseline and Month 12<br>Tabulation of the diabetes-related test values (i.e., glycosylated hemoglobin [HbA1c], fasting blood glucose level, and fasting insulin level) and the changes from baseline at each test time point (test value at each test time point after baseline – test value at baseline).