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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

494

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2020

Geographic Reach

1 country

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

March 17, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed

11 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed

Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

March 17, 2020

Last Update Submit

August 20, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (9)

Change in laboratory measured fasting plasma glucose (FPG)
From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured FPG
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (basal insulin)
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (prandial insulin)
From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (total insulin)
From baseline (week -12 to 0) to end of study (week 26-36)
+4 more secondary outcomes

Study Arms (1)

Tresiba®

Patients with type 2 diabetes

Drug: insulin degludec

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.

Tresiba®

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with type 2 diabetes

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.