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

NCT01065766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4065

Last updated 2015-03-06

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Sitagliptin/metformin

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-05-31
Completion
2013-05-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065766 on ClinicalTrials.gov