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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-5143 | 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 participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type 2 Diabetes requiring insulin therapy | Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec/Insulin Aspart | Drug | Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan |
| Measure | Description | Time Frame |
|---|---|---|
| Change in local laboratory measured glycosylated haemoglobin (HbA1c) | Measured in %point | From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total insulin dose | Measured in units/day | From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| Change in basal insulin dose |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes requiring insulin therapy
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Arakawa-ku, Tokyo | 116-0012 | Japan | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34304385 | Derived | Shigiyama F, Liu L, Nordahl H, Suzuki R, Yamamoto Y, Hirose T. A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan. Diabetes Ther. 2021 Sep;12(9):2405-2421. doi: 10.1007/s13300-021-01117-8. Epub 2021 Jul 25. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
Measured in units/day
| From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| Change in prandial insulin dose | Measured in units/day | From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| Change in local laboratory measured fasting plasma glucose (FPG) | Measured in mg/dL | From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks) |
| The incidence of patient recollection of non-severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| The incidence of patient recollection of overall severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| The incidence of patient recollection of nocturnal severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) |
| Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL) | Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL)) | From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0) |
| Chuo-ku, Tokyo |
| 103-0002 |
| Japan |
| Novo Nordisk Investigational Site | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Novo Nordisk Investigational Site | Fukushima | 963-8851 | Japan |
| Novo Nordisk Investigational Site | Higashiosaka-shi, Osaka | Japan |
| Novo Nordisk Investigational Site | Hokkaido | 062-0007 | Japan |
| Novo Nordisk Investigational Site | Hosu-gun, Ishikawa | 927-0053 | Japan |
| Novo Nordisk Investigational Site | Kanagawa | 235-0045 | Japan |
| Novo Nordisk Investigational Site | Kanagawa | 247-0055 | Japan |
| Novo Nordisk Investigational Site | Kawagoe-shi, Saitama | 350-0851 | Japan |
| Novo Nordisk Investigational Site | Kawaguchi-shi, Saitama | 332-0012 | Japan |
| Novo Nordisk Investigational Site | Kisarazu-shi, Chiba | 292-0038 | Japan |
| Novo Nordisk Investigational Site | Kita-ku, Tokyo | 114-0001 | Japan |
| Novo Nordisk Investigational Site | Nagano | 390-8621 | Japan |
| Novo Nordisk Investigational Site | Saitama-shi, Saitama | 336-0963 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060-0001 | Japan |
| Novo Nordisk Investigational Site | Sendai-shi, Miyagi | 980-0021 | Japan |
| Novo Nordisk Investigational Site | Shimotsuga-gun, Tochigi | 321-0204 | Japan |
| Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | 329-0433 | Japan |
| Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | 160-0023 | Japan |
| Novo Nordisk Investigational Site | Shizuoka-city, Shizuoka | 420-8630 | Japan |
| Novo Nordisk Investigational Site | Shizuoka-shi, Shizuoka | 420-0923 | Japan |
| Novo Nordisk Investigational Site | Shizuoka-shi, Shizuoka | 424-0853 | Japan |
| Novo Nordisk Investigational Site | Tochigi | 323-0022 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 113-8431 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 143-8541 | Japan |
| Novo Nordisk Investigational Site | Tsuchiura-shi,Ibaraki | 300-0062 | Japan |
| Novo Nordisk Investigational Site | Yaizu-shi, Shizuoka | 425-0022 | Japan |
| Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa | 223-0066 | Japan |
| 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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