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

August 20, 2021 updated by: Novo Nordisk A/S

A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Alushta, Russian Federation, 298500
        • Novo Nordisk Investigational Site
      • Belogorsk, Russian Federation, 297600
        • Novo Nordisk Investigational Site
      • Bryansk, Russian Federation, 242610
        • Novo Nordisk Investigational Site
      • Chapaevsk, Russian Federation, 446100
        • Novo Nordisk Investigational Site
      • Chelyabinsk, Russian Federation, 454048
        • Novo Nordisk Investigational Site
      • Dyurtyuli, Russian Federation, 452320
        • Novo Nordisk Investigational Site
      • Elista, Russian Federation, 358000
        • Novo Nordisk Investigational Site
      • Ivanovo, Russian Federation, 153012
        • Novo Nordisk Investigational Site
      • Kaluga, Russian Federation, 248002
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420073
        • Novo Nordisk Investigational Site
      • Krasnodar, Russian Federation, 350000
        • Novo Nordisk Investigational Site
      • Krasnoyarsk, Russian Federation, 660062
        • Novo Nordisk Investigational Site
      • Krasnoyarsk, Russian Federation, 660021
        • Novo Nordisk Investigational Site
      • Lipetsk, Russian Federation, 398043
        • Novo Nordisk Investigational Site
      • Lyskovo, Russian Federation, 606210
        • Novo Nordisk Investigational Site
      • Magnitogorsk, Russian Federation, 455016
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 111401
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 129226
        • Novo Nordisk Investigational Site
      • Moscow Region, Dolgoprudny, Russian Federation, 141707
        • Novo Nordisk Investigational Site
      • N. Novgorod, Russian Federation, 603155
        • Novo Nordisk Investigational Site
      • Odintsovo, Moscow Region, Russian Federation, 143003
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440039
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440066
        • Novo Nordisk Investigational Site
      • Rostov-on-Don, Russian Federation, 344004
        • Novo Nordisk Investigational Site
      • Saint-Peterburg, Russian Federation, 195256
        • Novo Nordisk Investigational Site
      • Saint-Peterburg, Russian Federation, 199004
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Samara, Russian Federation, 443111
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410005
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410033
        • Novo Nordisk Investigational Site
      • Sergiev Posad, Russian Federation, 141300
        • Novo Nordisk Investigational Site
      • Sevastopol, Russian Federation, 299011
        • Novo Nordisk Investigational Site
      • Sovetskiy, Russian Federation, 297200
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 193231
        • Novo Nordisk Investigational Site
      • Syktyvkar, Russian Federation, 167981
        • Novo Nordisk Investigational Site
      • Tula, Russian Federation, 300035
        • Novo Nordisk Investigational Site
      • Ufa, Russian Federation, 450038
        • Novo Nordisk Investigational Site
      • Voskresensk, Russian Federation, 140203
        • Novo Nordisk Investigational Site
      • Vyksa, Russian Federation, 607060
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in laboratory measured glycated haemoglobin (HbA1c) (% point)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
% point
From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured HbA1c (mmol/mol)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
mmol/mol
From baseline (week -12 to 0) to end of study (week 26-36)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in laboratory measured fasting plasma glucose (FPG)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
mg/dL
From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured FPG
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
mmol/L
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (basal insulin)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
units/day
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (prandial insulin)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
units/day
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (total insulin)
Time Frame: From baseline (week -12 to 0) to end of study (week 26-36)
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)
Number of participants per response option
After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Actual)

August 2, 2021

Study Completion (Actual)

August 2, 2021

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4589
  • U1111-1236-4887 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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