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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1236-4887 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 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 |
|---|---|---|---|
| Tresiba® | Patients with type 2 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec | Drug | Treatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory measured glycated haemoglobin (HbA1c) (% point) | % point | From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in laboratory measured HbA1c (mmol/mol) | mmol/mol | From baseline (week -12 to 0) to end of study (week 26-36) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory measured fasting plasma glucose (FPG) | mg/dL | From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in laboratory measured FPG | mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 2 diabetes
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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 | Alushta | 298500 | Russia | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
| From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in daily insulin doses (basal insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in daily insulin doses (prandial insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in daily insulin doses (total insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) |
| Change in number of patient reported overall non-severe hypoglycaemic episodes | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) |
| Change in number of patient reported nocturnal non-severe hypoglycaemic episodes | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) |
| Change in number of patient reported severe hypoglycaemic episodes (overall) | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) |
| Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options) | Number of participants per response option | After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36) |
| Belogorsk |
| 297600 |
| Russia |
| Novo Nordisk Investigational Site | Bryansk | 242610 | Russia |
| Novo Nordisk Investigational Site | Chapayevsk | 446100 | Russia |
| Novo Nordisk Investigational Site | Chelyabinsk | 454048 | Russia |
| Novo Nordisk Investigational Site | Dyurtyuli | 452320 | Russia |
| Novo Nordisk Investigational Site | Elista | 358000 | Russia |
| Novo Nordisk Investigational Site | Ivanovo | 153012 | Russia |
| Novo Nordisk Investigational Site | Kaluga | 248002 | Russia |
| Novo Nordisk Investigational Site | Kazan' | 420073 | Russia |
| Novo Nordisk Investigational Site | Krasnodar | 350000 | Russia |
| Novo Nordisk Investigational Site | Krasnoyarsk | 660021 | Russia |
| Novo Nordisk Investigational Site | Krasnoyarsk | 660062 | Russia |
| Novo Nordisk Investigational Site | Lipetsk | 398043 | Russia |
| Novo Nordisk Investigational Site | Lyskovo | 606210 | Russia |
| Novo Nordisk Investigational Site | Magnitogorsk | 455016 | Russia |
| Novo Nordisk Investigational Site | Moscow | 111401 | Russia |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 129226 | Russia |
| Novo Nordisk Investigational Site | Moscow Region, Dolgoprudny | 141707 | Russia |
| Novo Nordisk Investigational Site | Nizhny Novgorod | 603155 | Russia |
| Novo Nordisk Investigational Site | Odintsovo, Moscow Region | 143003 | Russia |
| Novo Nordisk Investigational Site | Penza | 440039 | Russia |
| Novo Nordisk Investigational Site | Penza | 440066 | Russia |
| Novo Nordisk Investigational Site | Rostov-on-Don | 344004 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 193231 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194358 | Russia |
| Novo Nordisk Investigational Site | Saint-Peterburg | 195256 | Russia |
| Novo Nordisk Investigational Site | Saint-Peterburg | 199004 | Russia |
| Novo Nordisk Investigational Site | Samara | 443111 | Russia |
| Novo Nordisk Investigational Site | Saratov | 410005 | Russia |
| Novo Nordisk Investigational Site | Saratov | 410033 | Russia |
| Novo Nordisk Investigational Site | Sergiyev Posad | 141300 | Russia |
| Novo Nordisk Investigational Site | Sevastopol’ | 299011 | Russia |
| Novo Nordisk Investigational Site | Sovetskiy | 297200 | Russia |
| Novo Nordisk Investigational Site | Syktyvkar | 167981 | Russia |
| Novo Nordisk Investigational Site | Tula | 300035 | Russia |
| Novo Nordisk Investigational Site | Ufa | 450038 | Russia |
| Novo Nordisk Investigational Site | Voskresensk | 140203 | Russia |
| Novo Nordisk Investigational Site | Vyksa | 607060 | Russia |
| 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 |
|---|---|
| C571886 | insulin degludec |
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