A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia
- Registration Number
- NCT03785522
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 597
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tresiba® Insulin degludec Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.
- Primary Outcome Measures
Name Time Method Change in HbA1c (mmol/mol) Week 0 (baseline), Week 26 (end of study) 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.
Change in glycated haemoglobin (HbA1c) (percentage) Week 0 (baseline), Week 26 (end of study) 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.
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose (FPG) (mg/dL) Week 0 (baseline), Week 26 (end of study) 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.
Change in daily insulin doses: Basal insulin Week 0 (baseline), Week 26 (end of study) 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.
Change in daily insulin doses: Prandial insulin Week 0 (baseline), Week 26 (end of study) 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.
Change in daily insulin doses: Total insulin Week 0 (baseline), Week 26 (end of study) 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.
Change in number of patient reported overall non-severe hypoglycaemic episodes Week -4 to 0, week 22 to 26 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.
Change in number of patient reported nocturnal non-severe hypoglycaemic episodes Week -4 to 0, week 22 to 26 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"?
Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable Week 26 Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation.
Change in FPG (mmol/L) Week 0 (baseline), Week 26 (end of study) 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.
Change in number of patient reported severe hypoglycaemic episodes (overall) Week -26 to 0, week 0 to 26 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.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇦Riyadh, Saudi Arabia