Korean Post-marketing Surveillance for Kombiglyze XR®

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01754142
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-24
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2016-09-01
• Study Completion: 2016-09-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 755

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of known and unexpected adverse events, especially serious adverse events	30 days after last dose of study drug (Approximately up to 4.5 years)
Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)	Baseline and Week 24 (for patients that have a post Week 12 follow-up visit)
Incidence of adverse events under the routine drug use	30 days after last dose of study drug (Approximately up to 4.5 years)

Secondary Outcome Measures

Name	Time	Method
Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs	Approximately up to 4.5 years
Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs	Approximately up to 4.5 years
Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs	Approximately up to 4.5 years	Adverse events (AEs)

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of