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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1145-9828 | Other Identifier | WHO | |
| ENCEPP/SDPP/6318 | Registry Identifier | EU PASS |
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This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with diabetes mellitus requiring insulin therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) by preferred term | During 1 year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAEs) by preferred term | During 1 year of treatment | |
| Incidence of serious adverse drug reactions (SADRs) by preferred term | During 1 year of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Guntur | Andhra Pradesh | 522001 | India | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Incidence of adverse drug reactions (ADRs) by preferred term |
| During 1 year of treatment |
| Incidence of severe hypoglycaemia | During 1 year of treatment |
| Change from baseline in glycosylated haemoglobin (HbA1c) | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) |
| Change from baseline in fasting plasma glucose (FPG) | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) |
| Incidence of confirmed hypoglycaemia | During 1 year of treatment |
| Hyderabad |
| Andhra Pradesh |
| 500001 |
| India |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500004 | India |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500072 | India |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | India |
| Novo Nordisk Investigational Site | Vijayawada | Andhra Pradesh | 520002 | India |
| Novo Nordisk Investigational Site | Guwahati | Assam | 781006 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380007 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India |
| Novo Nordisk Investigational Site | Ghuma | Gujarat | India |
| Novo Nordisk Investigational Site | Gurgaon | Haryana | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560092 | India |
| Novo Nordisk Investigational Site | Thrissur | Kerala | India |
| Novo Nordisk Investigational Site | Bhopal | Madhya Pradesh | 462037 | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | 452010 | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400053 | India |
| Novo Nordisk Investigational Site | Nagpur | Maharashtra | 440010 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411001 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411040 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | India |
| Novo Nordisk Investigational Site | Delhi | New Delhi | 110076 | India |
| Novo Nordisk Investigational Site | Delhi | New Delhi | India |
| Novo Nordisk Investigational Site | Mohali | Punjab | 160062 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600037 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600040 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600086 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600100 | India |
| Novo Nordisk Investigational Site | Coimbatore | Tamil Nadu | 641009 | India |
| Novo Nordisk Investigational Site | Coimbatore | Tamil Nadu | 641018 | India |
| Novo Nordisk Investigational Site | Madurai | Tamil Nadu | 625 020 | India |
| Novo Nordisk Investigational Site | Noida | Uttar Pradesh | 201301 | India |
| Novo Nordisk Investigational Site | Noida | Uttar Pradesh | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700054 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700094 | India |
| Novo Nordisk Investigational Site | Chennai | 600008 | India |
| Novo Nordisk Investigational Site | New Delhi | 110088 | India |
| Novo Nordisk Investigational Site | Thriruvananthapuram | 695 032 | India |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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