Korean Post-marketing Surveillance for Kombiglyze XR®

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes mellitus subjects initiating Kombiglyze XR<br>Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |