Januvia Re-examination Study (MK-0431-181)

NCT ID: NCT01062048

Last Updated: 2016-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-07-31

Brief Summary

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The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)

Sitagliptin

Intervention Type DRUG

Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label

Sulfonylurea

Intervention Type DRUG

Sulfonylurea administered in general use according to the local label

Insulin

Intervention Type BIOLOGICAL

Insulin administered in general use according to the local label

Interventions

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Sitagliptin

Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label

Intervention Type DRUG

Sulfonylurea

Sulfonylurea administered in general use according to the local label

Intervention Type DRUG

Insulin

Insulin administered in general use according to the local label

Intervention Type BIOLOGICAL

Other Intervention Names

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Januvia

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes Mellitus
* Treated With Januvia within local label for the first time


* Treated with Januvia for more than or equal to 24 weeks

Exclusion Criteria

* Contraindication to Januvia according to the local label
* Treated with Januvia 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 Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2010_003

Identifier Type: OTHER

Identifier Source: secondary_id

0431-181

Identifier Type: -

Identifier Source: org_study_id

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