Korean Post-marketing Surveillance for Kombiglyze XR®

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754142
• Other study ID #: CV181-306
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: August 7, 2017
• Start date: November 24, 2012
• Est. completion date: September 1, 2016

Study information

• Verified date: August 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Incidence of adverse events under the routine drug use		30 days after last dose of study drug (Approximately up to 4.5 years)
Primary	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 12
Primary	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)
Secondary	Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs	Adverse events (AEs)	Approximately up to 4.5 years
Secondary	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
Secondary	Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs		Approximately up to 4.5 years

External Links

•   CSR Synopsis
•   FDA Safety Alerts and Recalls