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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin/metformin

Study type: Observational

Funder types: Industry

Identifiers

NCT01065766

0431A-182

2010_006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4,065 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

4,065 participants in 1 patient group

All participants

Description:

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

Treatment:

Drug: Sitagliptin/metformin