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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1257-2534 | Other Identifier | World Health Organization (WHO) |
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This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ryzodeg | Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ryzodeg® | Drug | All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (Glycosylated Hemoglobin) | Percentage point | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with HbA1c less than 7.0 percentage (Yes or No) | Percentage of patients | At baseline (week 0) |
| Patients with HbA1c less than 7.0 percentage (Yes or No) | Percentage of patients |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Daejeon | 330-721 | South Korea | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38410023 | Derived | Kang S, Ahn YB, Oh TK, Lee WY, Chun SW, Bae B, Dahaoui A, Jeong JS, Jung S, Jang HC. Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus. Diabetes Metab J. 2024 Sep;48(5):929-936. doi: 10.4093/dmj.2023.0297. Epub 2024 Feb 27. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
| End of study (week 26) |
| Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) | Percentage of patients | At baseline (week 0) |
| Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) | Percentage of patients | End of study (week 26) |
| Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® | Number of events | Period 1(week-26 to week 0), Period 2(week 0 to week 26) |
| Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® | Number of events | Period 1(week-26 to week 0), Period 2(week 0 to week 26) |
| Change in FPG (Fasting Plasma Glucose) | mmol/L | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Change in daily total insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Change in daily basal insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Change in daily prandial insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Change in body weight | Kg | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |
| Daejeon |
| 361-711 |
| South Korea |
| Novo Nordisk Investigational Site | Seongnam-si | 463-707 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 03181 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 06273 | South Korea |
| Novo Nordisk Investigational Site | Suwon-si, Gyeonggi-do | 16247 | South Korea |
| 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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