Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day) in the routine clinical setting.

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Detailed Description

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This is a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus who respond poorly to pioglitazone hydrochloride monotherapy (pioglitazone at 15 mg/day).

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

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pioglitazone/glimepiride

Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.

Pioglitazone/glimepiride

Intervention Type DRUG

Pioglitazone/glimepiride combination tablets

Interventions

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Pioglitazone/glimepiride

Pioglitazone/glimepiride combination tablets

Intervention Type DRUG

Other Intervention Names

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Sonias combination tablets LD

Eligibility Criteria

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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 pioglitazone/glimepiride 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No