A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Tresiba® Patients with type 2 diabetes |
Drug: insulin degludec
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.
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Outcome Measures
Primary Outcome Measures
- Change in laboratory measured glycated haemoglobin (HbA1c) (% point) [From baseline (week -12 to 0) to end of study (week 26-36)]
% point
- Change in laboratory measured HbA1c (mmol/mol) [From baseline (week -12 to 0) to end of study (week 26-36)]
mmol/mol
Secondary Outcome Measures
- Change in laboratory measured fasting plasma glucose (FPG) [From baseline (week -12 to 0) to end of study (week 26-36)]
mg/dL
- Change in laboratory measured FPG [From baseline (week -12 to 0) to end of study (week 26-36)]
mmol/L
- Change in daily insulin doses (basal insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]
units/day
- Change in daily insulin doses (prandial insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]
units/day
- Change in daily insulin doses (total insulin) [From baseline (week -12 to 0) to end of study (week 26-36)]
units/day
- Change in number of patient reported overall non-severe hypoglycaemic 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)]
Number of episodes
- Change in number of patient reported nocturnal non-severe hypoglycaemic 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)]
Number of episodes
- Change in number of patient reported severe hypoglycaemic episodes (overall) [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)]
Number of episodes
- Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options) [After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)]
Number of participants per response option
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
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The decision to initiate treatment with commercially available Tresiba® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
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Male or female, age above or equal to 18 years at the time of signing informed consent.
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Diagnosed with type 2 diabetes and treated with any antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
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Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment.
Exclusion Criteria:
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Previous participation in this study. Participation is defined as having given informed consent in this study
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Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Novo Nordisk Investigational Site | Alushta | Russian Federation | 298500 | |
2 | Novo Nordisk Investigational Site | Belogorsk | Russian Federation | 297600 | |
3 | Novo Nordisk Investigational Site | Bryansk | Russian Federation | 242610 | |
4 | Novo Nordisk Investigational Site | Chapaevsk | Russian Federation | 446100 | |
5 | Novo Nordisk Investigational Site | Chelyabinsk | Russian Federation | 454048 | |
6 | Novo Nordisk Investigational Site | Dyurtyuli | Russian Federation | 452320 | |
7 | Novo Nordisk Investigational Site | Elista | Russian Federation | 358000 | |
8 | Novo Nordisk Investigational Site | Ivanovo | Russian Federation | 153012 | |
9 | Novo Nordisk Investigational Site | Kaluga | Russian Federation | 248002 | |
10 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420073 | |
11 | Novo Nordisk Investigational Site | Krasnodar | Russian Federation | 350000 | |
12 | Novo Nordisk Investigational Site | Krasnoyarsk | Russian Federation | 660021 | |
13 | Novo Nordisk Investigational Site | Krasnoyarsk | Russian Federation | 660062 | |
14 | Novo Nordisk Investigational Site | Lipetsk | Russian Federation | 398043 | |
15 | Novo Nordisk Investigational Site | Lyskovo | Russian Federation | 606210 | |
16 | Novo Nordisk Investigational Site | Magnitogorsk | Russian Federation | 455016 | |
17 | Novo Nordisk Investigational Site | Moscow Region, Dolgoprudny | Russian Federation | 141707 | |
18 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 111401 | |
19 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 117036 | |
20 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 129226 | |
21 | Novo Nordisk Investigational Site | N. Novgorod | Russian Federation | 603155 | |
22 | Novo Nordisk Investigational Site | Odintsovo, Moscow Region | Russian Federation | 143003 | |
23 | Novo Nordisk Investigational Site | Penza | Russian Federation | 440039 | |
24 | Novo Nordisk Investigational Site | Penza | Russian Federation | 440066 | |
25 | Novo Nordisk Investigational Site | Rostov-on-Don | Russian Federation | 344004 | |
26 | Novo Nordisk Investigational Site | Saint-Peterburg | Russian Federation | 195256 | |
27 | Novo Nordisk Investigational Site | Saint-Peterburg | Russian Federation | 199004 | |
28 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194358 | |
29 | Novo Nordisk Investigational Site | Samara | Russian Federation | 443111 | |
30 | Novo Nordisk Investigational Site | Saratov | Russian Federation | 410005 | |
31 | Novo Nordisk Investigational Site | Saratov | Russian Federation | 410033 | |
32 | Novo Nordisk Investigational Site | Sergiev Posad | Russian Federation | 141300 | |
33 | Novo Nordisk Investigational Site | Sevastopol | Russian Federation | 299011 | |
34 | Novo Nordisk Investigational Site | Sovetskiy | Russian Federation | 297200 | |
35 | Novo Nordisk Investigational Site | St. Petersburg | Russian Federation | 193231 | |
36 | Novo Nordisk Investigational Site | Syktyvkar | Russian Federation | 167981 | |
37 | Novo Nordisk Investigational Site | Tula | Russian Federation | 300035 | |
38 | Novo Nordisk Investigational Site | Ufa | Russian Federation | 450038 | |
39 | Novo Nordisk Investigational Site | Voskresensk | Russian Federation | 140203 | |
40 | Novo Nordisk Investigational Site | Vyksa | Russian Federation | 607060 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN1250-4589
- U1111-1236-4887