Type 2 diabetes mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : Sonias Combination Tablets LD (pioglitazone/glimepiride 15mg/1mg)
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes mellitus for whom treatment with pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) is considered inefficacious as per physician's assessment and for whom long-term treatment with Sonias Combination Tablets LD is considered necessary
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframeFor 12 months 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
| Measure | Time frame |
|---|---|
| Changes from the baseline in diabetes-related test values Secondary timeframeBaseline and month 12 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). | — |
Outcome results
None listed