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Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

NCT ID: NCT02003014

Last Updated: 2016-11-10

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

899 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

Brief Summary

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To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

Detailed Description

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This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 45 mg.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Drug Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pioglitazone 15 mg to 30 mg

administered orally once daily

Pioglitazone

Intervention Type DRUG

Pioglitazone Tablets

Interventions

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Pioglitazone

Pioglitazone Tablets

Intervention Type DRUG

Other Intervention Names

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Actos

Eligibility Criteria

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Inclusion Criteria

1. Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
2. Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
3. Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Exclusion Criteria

1. Patients who have received Actos Tablets within the past 3 months.
2. Patients who started treatment with biguanides and Actos Tablets simultaneously
3. Patients who discontinued biguanides and switched to Actos Tablets treatment.
4. Patients who received additional biguanides after the start of Actos Tablets treatment
5. Patients with contraindications to Actos Tablets treatment
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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Postmarketing Group Manager

Role: STUDY_CHAIR

Takeda

Other Identifiers

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JapicCTI-132329

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-R160828

Identifier Type: REGISTRY

Identifier Source: secondary_id

237-017

Identifier Type: -

Identifier Source: org_study_id