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

Novo Nordisk A/S494 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

494

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludecDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

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

% point

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

Change in laboratory measured HbA1c (mmol/mol)

mmol/mol

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

Secondary Outcomes

Change in laboratory measured fasting plasma glucose (FPG)

mg/dL

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

Change in laboratory measured FPG

mmol/L

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

Change in daily insulin doses (basal insulin)

units/day

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

Change in daily insulin doses (prandial insulin)

units/day

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

Change in daily insulin doses (total insulin)

units/day

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

Change in number of patient reported overall non-severe hypoglycaemic episodes

Number of 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)

Data from ClinicalTrials.gov

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