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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1157-0615 | Other Identifier | World Health Organization (WHO) | |
| ENCEPP/SDPP/6587 | Registry Identifier | EU PASS |
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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 diabetes mellitus in routine clinical practice in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ryzodeg™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/insulin aspart | Drug | Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Weeks 0-52 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAEs) | Weeks 0-52 | |
| Serious Adverse Drug Reactions (SADRs) | Weeks 0-52 | |
| Adverse Drug Reactions (ADRs) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diabetes where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.
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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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| Weeks 0-52 |
| Severe or Blood glucose (BG) Confirmed hypoglycaemia | Weeks 0-52 |
| Change in HbA1c (glycosylated haemoglobin) | Week 0, week 52 |
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 52 |
| Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) | Week 0, week 52 |
| The reason for initiating or intensifying treatment with Ryzodeg™ | Week 0 - week 52 |
| Vijayawada |
| Andhra Pradesh |
| 520002 |
| India |
| Novo Nordisk Investigational Site | Visakhapatnam | Andhra Pradesh | 530002 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380007 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380052 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | India |
| Novo Nordisk Investigational Site | Gandhinagar | Gujarat | 382428 | India |
| Novo Nordisk Investigational Site | Ghuma | Gujarat | India |
| Novo Nordisk Investigational Site | Surat | Gujarat | 395002 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560092 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | India |
| Novo Nordisk Investigational Site | Mangalore | Karnataka | 575001 | India |
| Novo Nordisk Investigational Site | Angamaly | Kerala | India |
| Novo Nordisk Investigational Site | Kochi | Kerala | 682041 | India |
| Novo Nordisk Investigational Site | Thrissur | Kerala | India |
| Novo Nordisk Investigational Site | Trivandrum | Kerala | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | 452008 | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400053 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411001 | India |
| Novo Nordisk Investigational Site | Amritsar | Punjab | India |
| Novo Nordisk Investigational Site | Chandigarh | Punjab | India |
| Novo Nordisk Investigational Site | Jaipur | Rajasthan | 302017 | India |
| Novo Nordisk Investigational Site | Jaipur | Rajasthan | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600037 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600100 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India |
| Novo Nordisk Investigational Site | Coimbatore | Tamil Nadu | 641009 | India |
| Novo Nordisk Investigational Site | Madurai | Tamil Nadu | 625 020 | India |
| Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh | 226005 | India |
| Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh | India |
| Novo Nordisk Investigational Site | Noida | Uttar Pradesh | 201301 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700054 | India |
| Novo Nordisk Investigational Site | Bilāspur | 495001 | 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 |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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