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

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785522
• Other study ID #: NN1250-4440
• Secondary ID: U1111-1208-5065
• Status: Completed
• Start date: December 23, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Novo Nordisk Investigational Site	Al Jubayl
Saudi Arabia	Novo Nordisk Investigational Site	Al Khobar
Saudi Arabia	Novo Nordisk Investigational Site	Al Khobar
Saudi Arabia	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	Makkah
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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in fasting plasma glucose (FPG) (mg/dL)	Measured in mg/dL. 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	Change in FPG (mmol/L)	Measured in mmol/L. 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	Change in daily insulin doses: Basal insulin	Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). 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	Change in daily insulin doses: Prandial insulin	Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). 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	Change in daily insulin doses: Total insulin	Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). 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	Change in number of patient reported overall non-severe hypoglycaemic episodes	Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. Non-severe hypoglycaemia is defined as an episode with symptoms and/or self-measured blood glucose (SMBG) value less than or equal to 3.9 mmol/L.	Week -4 to 0, week 22 to 26
Secondary	Change in number of patient reported nocturnal non-severe hypoglycaemic episodes	Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. The definition of "nocturnal" will be based on the patient's perception of whether or not it was night, i.e. the answer to this question to the patient: "How many of these occurred between midnight and early morning"?	Week -4 to 0, week 22 to 26
Secondary	Change in number of patient reported severe hypoglycaemic episodes (overall)	Number of episodes occurring within 26 weeks prior to initiation of treatment with Tresiba® and within 26 weeks prior to end of study. Severe hypoglycaemia is defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action. The patient should be asked: "Were you able to treat yourself?", if assistance from another person was required the episode can be defined as severe.	Week -26 to 0, week 0 to 26
Secondary	Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable	Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation.	Week 26