Clinical trial NCT03785522: A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia
Official title: A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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/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:

* 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

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c) (percentage)
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in HbA1c (mmol/mol)
timeFrame: Week 0 (baseline), Week 26 (end of study)
Secondary outcomes:
measure: Change in fasting plasma glucose (FPG) (mg/dL)
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in FPG (mmol/L)
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in daily insulin doses: Basal insulin
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in daily insulin doses: Prandial insulin
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in daily insulin doses: Total insulin
timeFrame: Week 0 (baseline), Week 26 (end of study)
measure: Change in number of patient reported overall non-severe hypoglycaemic episodes
timeFrame: Week -4 to 0, week 22 to 26
measure: Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
timeFrame: Week -4 to 0, week 22 to 26
measure: Change in number of patient reported severe hypoglycaemic episodes (overall)
timeFrame: Week -26 to 0, week 0 to 26
measure: Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable
timeFrame: Week 26
Other outcomes:
Locations:
city: Al Jubayl
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Al Khobar
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Al Khobar
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: AL Qateef
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Dammam
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Dammam
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Dammam
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Ihsa
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Makkah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: