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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec

• Registration Number: NCT04315688
• Lead Sponsor: Novo Nordisk A/S

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Study Start: 2020-03-30
• Status Verified: 2021-08
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-02
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tresiba®	insulin degludec	Patients with type 2 diabetes

Primary Outcome Measures

Name	Time	Method
Change in laboratory measured HbA1c (mmol/mol)	From baseline (week -12 to 0) to end of study (week 26-36)	mmol/mol
Change in laboratory measured glycated haemoglobin (HbA1c) (% point)	From baseline (week -12 to 0) to end of study (week 26-36)	% point

Secondary Outcome Measures

Name	Time	Method
Change in laboratory measured fasting plasma glucose (FPG)	From baseline (week -12 to 0) to end of study (week 26-36)	mg/dL
Change in daily insulin doses (basal insulin)	From baseline (week -12 to 0) to end of study (week 26-36)	units/day
Change in number of patient reported severe hypoglycaemic episodes (overall)	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
Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)	After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)	Number of participants per response option
Change in laboratory measured FPG	From baseline (week -12 to 0) to end of study (week 26-36)	mmol/L
Change in daily insulin doses (prandial insulin)	From baseline (week -12 to 0) to end of study (week 26-36)	units/day
Change in number of patient reported overall non-severe hypoglycaemic 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)	Number of episodes
Change in number of patient reported nocturnal non-severe hypoglycaemic 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)	Number of episodes
Change in daily insulin doses (total insulin)	From baseline (week -12 to 0) to end of study (week 26-36)	units/day

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇺 Vyksa, Russian Federation