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

NCT ID: NCT01990300

Last Updated: 2023-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3281 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-28

Study Completion Date

2015-03-31

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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alogliptin/Pioglitazone combination tablets

Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.

Alogliptin/Pioglitazone

Intervention Type DRUG

Alogliptin/Pioglitazone combination tablets

Interventions

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Alogliptin/Pioglitazone

Alogliptin/Pioglitazone combination tablets

Intervention Type DRUG

Other Intervention Names

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Liovel、SYR-322-4833

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:

1. Patients with current cardiac failure or a past history of cardiac failure
2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
3. Patients with serious hepatic dysfunction
4. Patients with serious renal dysfunction
5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
6. Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
7. Pregnant or possibly pregnant women
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Someplace, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-132302

Identifier Type: REGISTRY

Identifier Source: secondary_id

136-011

Identifier Type: -

Identifier Source: org_study_id

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