Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

Detailed Description
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This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting. Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000. The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Official Title
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Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Alogliptin/Pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus Exclusion Criteria: Patients meeting any of the following criteria will be excluded: Patients with current cardiac failure or a past history of cardiac failure Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus Patients with serious hepatic dysfunction Patients with serious renal dysfunction Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone Pregnant or possibly pregnant women
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 |
| --- | --- |
| Alogliptin/Pioglitazone combination tablets<br>Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. | Drug: Alogliptin/Pioglitazone<br>* Alogliptin/Pioglitazone combination tablets<br>* Other names: Liovel、SYR-322-4833;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Events |  | Up to 12 Months | 
| Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Fasting Blood Glucose (FBG) | Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy