Status:
COMPLETED
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- 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.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- 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).
- Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment.
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
Key Trial Info
Start Date :
March 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2021
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT04315688
Start Date
March 30 2020
End Date
August 2 2021
Last Update
August 23 2021
Active Locations (40)
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1
Novo Nordisk Investigational Site
Alushta, Russia, 298500
2
Novo Nordisk Investigational Site
Belogorsk, Russia, 297600
3
Novo Nordisk Investigational Site
Bryansk, Russia, 242610
4
Novo Nordisk Investigational Site
Chapayevsk, Russia, 446100