Korean Post-marketing Surveillance for Kombiglyze XR®

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01754142

Enrollment

755

Registered

2012-12-21

Start date

2012-11-24

Completion date

2016-09-01

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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)
Incidence of adverse events under the routine drug use	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 12

Secondary

Measure	Time frame	Description
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)
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 overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs	Approximately up to 4.5 years	—

Countries

South Korea

Outcome results