Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Pioglitazone/glimepiride

• Registration Number: NCT02098733
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Detailed Description

This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.

The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-12-16
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Results First Posted: 2016-04-15
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1168

Inclusion Criteria

• 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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pioglitazone/glimepiride	Pioglitazone/glimepiride	Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	For 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, and Months 3, 6, 9, 12 and at Final Assessment	Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
Glycosylated Hemoglobin (HbA1c)	Baseline, and Months 3, 6, 9, 12 and at Final Assessment	Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.
Change From Baseline in Fasting Insulin Level	Baseline, Months 3, 6, 9, 12 and at Final Assessment	Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
Change From Baseline in Fasting Blood Glucose Level	Baseline, Months 3, 6, 9, 12 and at Final Assessment	Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.
Fasting Blood Glucose Level	Baseline, Months 3, 6, 9, 12 and at Final Assessment	Tabulated fasting blood glucose level from baseline at each test time point.
Fasting Insulin Level	Baseline, Months 3, 6, 9, 12 and at Final Assessment	Tabulated fasting insulin level at each test time point.