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A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia

NCT ID: NCT04315688

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-08-02

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tresiba®

Patients with type 2 diabetes

insulin degludec

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Alushta, , Russia

Site Status

Novo Nordisk Investigational Site

Belogorsk, , Russia

Site Status

Novo Nordisk Investigational Site

Bryansk, , Russia

Site Status

Novo Nordisk Investigational Site

Chapayevsk, , Russia

Site Status

Novo Nordisk Investigational Site

Chelyabinsk, , Russia

Site Status

Novo Nordisk Investigational Site

Dyurtyuli, , Russia

Site Status

Novo Nordisk Investigational Site

Elista, , Russia

Site Status

Novo Nordisk Investigational Site

Ivanovo, , Russia

Site Status

Novo Nordisk Investigational Site

Kaluga, , Russia

Site Status

Novo Nordisk Investigational Site

Kazan', , Russia

Site Status

Novo Nordisk Investigational Site

Krasnodar, , Russia

Site Status

Novo Nordisk Investigational Site

Krasnoyarsk, , Russia

Site Status

Novo Nordisk Investigational Site

Krasnoyarsk, , Russia

Site Status

Novo Nordisk Investigational Site

Lipetsk, , Russia

Site Status

Novo Nordisk Investigational Site

Lyskovo, , Russia

Site Status

Novo Nordisk Investigational Site

Magnitogorsk, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow Region, Dolgoprudny, , Russia

Site Status

Novo Nordisk Investigational Site

Nizhny Novgorod, , Russia

Site Status

Novo Nordisk Investigational Site

Odintsovo, Moscow Region, , Russia

Site Status

Novo Nordisk Investigational Site

Penza, , Russia

Site Status

Novo Nordisk Investigational Site

Penza, , Russia

Site Status

Novo Nordisk Investigational Site

Rostov-on-Don, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint-Peterburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint-Peterburg, , Russia

Site Status

Novo Nordisk Investigational Site

Samara, , Russia

Site Status

Novo Nordisk Investigational Site

Saratov, , Russia

Site Status

Novo Nordisk Investigational Site

Saratov, , Russia

Site Status

Novo Nordisk Investigational Site

Sergiyev Posad, , Russia

Site Status

Novo Nordisk Investigational Site

Sevastopol’, , Russia

Site Status

Novo Nordisk Investigational Site

Sovetskiy, , Russia

Site Status

Novo Nordisk Investigational Site

Syktyvkar, , Russia

Site Status

Novo Nordisk Investigational Site

Tula, , Russia

Site Status

Novo Nordisk Investigational Site

Ufa, , Russia

Site Status

Novo Nordisk Investigational Site

Voskresensk, , Russia

Site Status

Novo Nordisk Investigational Site

Vyksa, , Russia

Site Status

Countries

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Russia

Other Identifiers

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U1111-1236-4887

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-4589

Identifier Type: -

Identifier Source: org_study_id

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