A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia
NCT ID: NCT03785522
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
597 participants
OBSERVATIONAL
2018-12-23
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tresiba®
Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.
Insulin degludec
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.
Interventions
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Insulin degludec
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
AL Qateef, , Saudi Arabia
Novo Nordisk Investigational Site
Dammam, , Saudi Arabia
Novo Nordisk Investigational Site
Dammam, , Saudi Arabia
Novo Nordisk Investigational Site
Dammam, , Saudi Arabia
Novo Nordisk Investigational Site
Ihsa, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Jubail, , Saudi Arabia
Novo Nordisk Investigational Site
Khobar, , Saudi Arabia
Novo Nordisk Investigational Site
Khobar, , Saudi Arabia
Novo Nordisk Investigational Site
Mecca, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Countries
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References
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AlMalki MH, Aldesokey H, Alkhafaji D, Alsheikh A, Braae UC, Lehrskov LL, Magawry W, Yahia M, Haroun A. Glycaemic Control in People with Type 2 Diabetes Treated with Insulin Degludec: A Real-World, Prospective Non-interventional Study-UPDATES Saudi Arabia. Adv Ther. 2023 Feb;40(2):568-584. doi: 10.1007/s12325-022-02366-0. Epub 2022 Nov 22.
Other Identifiers
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U1111-1208-5065
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-4440
Identifier Type: -
Identifier Source: org_study_id
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