Sonias Combination Tablets LD special drug use surveillance Survey on Type 2 diabetes mellitus: Insufficient treatment response to Pioglitazone

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCT1080222395
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 210

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

(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 timeframeFor 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 the baseline in diabetes-related test values<br>Secondary timeframeBaseline 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).