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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey on Long-term Use for in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Pioglitazone/glimepiride


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pioglitazone/glimepiride<br>Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast | Drug: Pioglitazone/glimepiride<br>* Pioglitazone/glimepiride combination tablets<br>* Other names: Sonias combination tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions | 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. | For 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | 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. | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | 
| Glycosylated Hemoglobin (HbA1c) | 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. | Baseline, and Months 3, 6, 9, 12 and at Final Assessment | 
| Change From Baseline in Fasting Blood Glucose Level | 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. | Baseline, Months 3, 6, 9, 12 and at Final Assessment | 
| Fasting Blood Glucose Level | Tabulated fasting blood glucose level from baseline at each test time point. | Baseline, Months 3, 6, 9, 12 and at Final Assessment | 
| Change From Baseline in Fasting Insulin Level | 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. | Baseline, Months 3, 6, 9, 12 and at Final Assessment | 
| Fasting Insulin Level | Tabulated fasting insulin level at each test time point. | Baseline, Months 3, 6, 9, 12 and at Final Assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy