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Completed

NCT Number: NCT04315688

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Alushta, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in laboratory measured glycated haemoglobin (HbA1c) (% point)

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    % point

  2. Change in laboratory measured HbA1c (mmol/mol)

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    mmol/mol

Secondary outcomes

  1. 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

  2. Change in laboratory measured FPG

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    mmol/L

  3. Change in daily insulin doses (basal insulin)

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    units/day

  4. Change in daily insulin doses (prandial insulin)

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    units/day

  5. Change in daily insulin doses (total insulin)

    Time frame: From baseline (week -12 to 0) to end of study (week 26-36)

    units/day

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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