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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Biological: Insulin; Drug: Sulfonylurea

Study type: Observational

Funder types: Industry

Identifiers

NCT01062048

2010_003 (Other Identifier)

0431-181

Details and patient eligibility

About

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.

Enrollment: 3,483 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Contraindication to Januvia according to the local label
• Treated with Januvia before contract and out of enrollment period

Inclusion criteria for long-term surveillance

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

Trial design

3,483 participants in 1 patient group

All participants

Description:

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)

Treatment:

Biological: Insulin

Drug: Sitagliptin

Drug: Sulfonylurea