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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes mellitus subjects initiating Kombiglyze XR | Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled |
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| 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) |
| 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 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Seoul | South Korea |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |