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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1185-0871 | Other Identifier | WHO |
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Request for the study waived by Indian Health Authorities
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This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec /liraglutide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | Patients will be treated with commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent Adverse Events (AEs) | Count and % of events | Year 0-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Count and % of events | Year 0-1 |
| Number of Serious Adverse Drug Reactions (SADRs) | Count and % of events |
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Inclusion Criteria:
Exclusion Criteria:
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Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Year 0-1 |
| Number of Adverse Drug Reactions (ADRs) | Count and % of events | Year 0-1 |
| Number of confirmed hypoglycaemic episodes | Count of episodes | Year 0-1 |
| Change from baseline in the level of glycosylated haemoglobin (HbA1c) | Measured in % | Year 0, Year 1 |
| Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline | Measured in mg/dl or other equivalent SI units | Year 0, Year 1 |
| Percentage of patients achieving the target level of HbA1c below 7% | Measured in % | Year 1 |
| Change in body weight | Measured in kg and/or % | Year 0, Year 1 |
| Number of patients withdrawn due to ineffective therapy | Count of withdrawals | Year 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
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