Korean Post-marketing Surveillance for Kombiglyze XR®

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Industry

Identifiers

NCT01754142

CV181-306

Details and patient eligibility

About

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly

Enrollment: 755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• ≥ 18 years of age
• Have diagnosed Type 2 diabetes mellitus (T2DM)
• Are initiating Kombiglyze XR treatment within the approved Korean indications

Exclusion Criteria:

• Being treated for an indication not approved for the use of Kombiglyze XR in Korea
• Is contraindicated for the use of Kombiglyze XR as described in the Korean label

Trial design

755 participants in 1 patient group

Type 2 diabetes mellitus subjects initiating Kombiglyze XR

Description:

Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled