Brief Summary

The purpose of the study is to collect information on how Tresiba® works in real world patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study will last for about 6 to 8 months. Patients will be asked questions about their health and diabetes treatment as part of their normal study doctor's appointment.

Trial Health

On Track

Trial Health Score

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

Enrollment

597

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Geographic Reach

1 country

21 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

1.9 years study duration

First Submitted

Initial submission to the registry

December 20, 2018

Completed

3 days until next milestone

Study Start

First participant enrolled

December 23, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed

Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

December 20, 2018

Last Update Submit

June 3, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in glycated haemoglobin (HbA1c) (percentage)
Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
Week 0 (baseline), Week 26 (end of study)
Change in HbA1c (mmol/mol)
Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
Week 0 (baseline), Week 26 (end of study)

Secondary Outcomes (9)

Change in fasting plasma glucose (FPG) (mg/dL)
Week 0 (baseline), Week 26 (end of study)
Change in FPG (mmol/L)
Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Basal insulin
Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Prandial insulin
Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Total insulin
Week 0 (baseline), Week 26 (end of study)
+4 more secondary outcomes

Study Arms (1)

Tresiba®

Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.

Drug: Insulin degludec

Interventions

Insulin degludecDRUG

Patients will be treated with commercially available Tresiba® in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba® as well as any dose adjustments thereafter.

Also known as: Tresiba®

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 in Saudi Arabia treated with any antihyperglycaemic medication(s), except Tresiba®, are eligible for this study.

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/legally acceptable representative 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 antihyperglycaemic medication(s), except Tresiba®, for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1)
Available and documented HbA1c value measured within the last 12 weeks 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.