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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

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