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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1227-8654 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ryzodeg® as per local practice | Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec/Insulin Aspart | Drug | Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory measured glycosylated haemoglobin (HbA1c) | Percentage point | From baseline (week 0) to end of study (week 26-36) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c less than 7% (Yes/No) | Percentage of patients | At the end of study (week 26-36) |
| HbA1c less than pre-defined individual treatment target (Yes/No) | Percentage of patients |
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Inclusion Criteria:
Exclusion Criteria:
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Real-world population of type 2 patients, who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia | ||
| Illawarra Diabetes Service Clinical Trials & Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39171857 | Result | Fulcher GR, Cohen ND, Davies K, d'Emden M, Glastras SJ, Mah PM, McCallum RW, Moses R, Thong KY, Roberts A. Initiating or switching to insulin degludec/insulin aspart in a real-world population of adults with type 2 diabetes in Australia: results from a prospective, non-interventional study. Intern Med J. 2024 Oct;54(10):1626-1633. doi: 10.1111/imj.16492. Epub 2024 Aug 22. | |
| 39464932 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
| At the end of study (week 26-36) |
| Change in local laboratory measured fasting plasma glucose (FPG) | mg/dL | From baseline (week 0) to end of study (week 26-36) |
| Change in local laboratory measured FPG | mmol/L | From baseline (week 0) to end of study (week 26-36) |
| Change in insulin dose (total, basal, prandial) | units/day | From baseline (week 0) to end of study (week 26-36) |
| Change in body weight | Kg | From baseline (week 0) to end of study (week 26-36) |
| Number of patient recollection of non-severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® |
| Number of patient recollection of non-severe hypoglycaemic episodes | Number of episodes | At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study |
| Number of patient recollection of nocturnal non-severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® |
| Number of patient recollection of nocturnal non-severe hypoglycaemic episodes | Number of episodes | At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study |
| Number of patient recollection of overall severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® |
| Number of patient recollection of overall severe hypoglycaemic episodes | Number of episodes | At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study |
| Number of weekly self-measured plasma glucose (SMPG) measurements | Number of measurements | At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg® |
| Number of weekly self-measured plasma glucose (SMPG) measurements | Number of measurements | At end of study (week 26-36). Measurements occurring within 7 days prior to end of study |
| Reason for initiating Ryzodeg® (pre-specified response option(s)) | Percentage of patients per response option | At baseline (week 0) |
| Discontinue treatment with Ryzodeg® during the treatment period (Yes/No) | Percentage of patients | At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation |
| Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s)) | Percentage of patients per response option | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation |
| Time period from initiation to discontinuation of treatment with Ryzodeg® | Days | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation |
| Wollongong |
| New South Wales |
| 2500 |
| Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Mater Hospital Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Lyell McEwin Hospital | Elizabeth Vale | South Australia | 5112 | Australia |
| South Australian Endocrine Research | Keswick | South Australia | 5035 | Australia |
| Hobart Cardiology | Hobart | Tasmania | 7000 | Australia |
| Box Hill Specialist Consulting rooms | Box Hill | Victoria | 3128 | Australia |
| Baker IDI Heart and Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
| Rockingham General Hospital | Cooloongup | Western Australia | 6168 | Australia |
| Excelcare Hospital | Guwahati | Assam | 781033 | India |
| Columbia Asia Hospital | Bangalore | Karnataka | 560024 | India |
| Pace Diabetes Center | Bangalore | Karnataka | 560043 | India |
| DEW Medicare & Trinity hospital | Nagpur | Maharashtra | 440015 | India |
| Max Super Speciality Shalimar Bhagh | Delhi | New Delhi | 110088 | India |
| AMRI Hospital | Bhubaneswar | Odisha | 751030 | India |
| Fortis Heart Institute and Multispeciality Hospital | Mohali | Punjab | 160062 | India |
| R.M. Diabetes Education & Research Foundation | Chennai | Tamil Nadu | 600040 | India |
| Narayana Superspeciality Hospital | Howrah | West Bengal | 711103 | India |
| Fortis Hospital | New Delhi | 110088 | India |
| Island Hospital | George Town | 10450 | Malaysia |
| Remedic Clinic | Kangar | 01000 | Malaysia |
| Pantai Hospital | Kedah | 08000 | Malaysia |
| Kota Bahru Medical Centre Sdn Bhd | Kelantan | 15200 | Malaysia |
| Hospital Universiti Sains Malaysia | Kota Bharu, Kelantan | 16150 | Malaysia |
| Gleneagles Hospital | Kuala Lumpur | 50450 | Malaysia |
| Subang Jaya Medical Center | Kuala Selangor | 47500 | Malaysia |
| Thomson Hospital | Kuala Selangor | 47810 | Malaysia |
| Borneo Medical Centre | Kuching | 93350 | Malaysia |
| KPJ Kuching | Kuching | 93350 | Malaysia |
| Mahkota Medical Center | Malacca | 75000 | Malaysia |
| Pantai Hospital Ayer Keroh | Malacca | 75450 | Malaysia |
| Klinik Chong | Perak | 35800 | Malaysia |
| Hospital Putrajaya | Putrajaya | 62250 | Malaysia |
| Panay Healthcare Medical Center | Aklan | Philippines |
| Perpetual Succor Hospital | Cebu City | Philippines |
| Davao Doctors Hospital | Davao City | 8000 | Philippines |
| Iloilo Diabetes Care Center | Iloilo City | 5000 | Philippines |
| Makati Medical Center | Makati City | 1229 | Philippines |
| University of Santo Tomas | Manila | 1015 | Philippines |
| Manila Doctor's Hospital | Manila | Philippines |
| University of Sto. Tomas Hospital | Manila | Philippines |
| St. Luke's Medical Center | Quezon City | 1102 | Philippines |
| Providence Hospital | Quezon City | Philippines |
| University of the East-Ramon Magsaysay Memorial Medical Ctr | Quezon City | Philippines |
| King Abdulaziz University Hospital | Jeddah | 22252 | Saudi Arabia |
| Dr Bakhsh Hospital | Jeddah | 23216 | Saudi Arabia |
| Dr. Ghassan N. Faroun Hospital | Jeddah | 23521 | Saudi Arabia |
| Saudi German Hospital | Jeddah | 23521 | Saudi Arabia |
| My clinic | Jeddah | Saudi Arabia |
| Umm Alquara University Hospital | Mecca | 24381 | Saudi Arabia |
| Specialized medical center | Riyadh | 12311 | Saudi Arabia |
| Riyadh Care Hospital | Riyadh | 14214 | Saudi Arabia |
| National Guard Hospital | Riyadh | 14611 | Saudi Arabia |
| Dallah Hospital | Riyadh | 14963 | Saudi Arabia |
| Greenacres Hospital | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Netcare Greenacres Hospital | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| ProHealth Wellness Centre | Port Elizabeth | Eastern Cape | 6201 | South Africa |
| Hemant Makan | Johannesburg | Gauteng | 1827 | South Africa |
| Dr Moosa's Rooms | Lenasia | Gauteng | 1827 | South Africa |
| Prof P. Joshi | Pretoria | Gauteng | 0181 | South Africa |
| Dr H Bacus | Berea | KwaZulu-Natal | 4091 | South Africa |
| Union Hospital | Alberton | 1449 | South Africa |
| Medi-Clinic Bloemfontein | Bloemfontein | 9301 | South Africa |
| Derived |
| Baruah MP, Aneja P, Pitale S, Bhograj A, Agrawala RK, Aggarwal A, Mahadev PG, Madhavdas DC, Shah S, John M, Pathan MKA, Revanna M, Chandrappa M, Singh KP. Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study. J Family Med Prim Care. 2024 Sep;13(9):3590-3597. doi: 10.4103/jfmpc.jfmpc_1401_23. Epub 2024 Sep 11. |
| 35752730 | Derived | Fulcher GR, Akhtar S, Al-Jaser SJ, Medina J, Mohamed M, Nicodemus NA Jr, Olsen AH, Singh KP, Kok A. Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries. Adv Ther. 2022 Aug;39(8):3735-3748. doi: 10.1007/s12325-022-02212-3. Epub 2022 Jun 25. |
| 34637072 | Derived | Fulcher GR, Jarlov H, Piltoft JS, Singh KP, Liu L, Mohamed M, Nicodemus NA Jr, Al-Jaser SJ, Kok A. ARISE-a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design. Endocrine. 2021 Dec;74(3):530-537. doi: 10.1007/s12020-021-02887-8. Epub 2021 Oct 12. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C578220 | insulin degludec, insulin aspart drug combination |
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