Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

NCT ID: NCT01065766

Last Updated: 2015-03-06

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

4065 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-05-31

Brief Summary

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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin

Sitagliptin/metformin

Intervention Type DRUG

Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.

Interventions

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Sitagliptin/metformin

Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.

Intervention Type DRUG

Other Intervention Names

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JANUMET

Eligibility Criteria

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Inclusion Criteria

* Has type 2 diabetes mellitus
* Is treated with sitagliptin/metformin within local label for the first time

Exclusion Criteria

* Has a contraindication to sitagliptin/metformin according to the local label
* Is treated with sitagliptin/metformin before contract and out of enrollment period
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2010_006

Identifier Type: OTHER

Identifier Source: secondary_id

0431A-182

Identifier Type: -

Identifier Source: org_study_id

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