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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin degludec

• Study Type: Observational
• Enrollment (Actual): 597

Contacts and Locations

Study Locations

• Saudi Arabia
  • AL Qateef, Saudi Arabia, 31911
    • Novo Nordisk Investigational Site
  • Al Jubayl, Saudi Arabia, 35718
    • Novo Nordisk Investigational Site
  • Al Khobar, Saudi Arabia, 34234
    • Novo Nordisk Investigational Site
  • Al Khobar, Saudi Arabia, 34425
    • Novo Nordisk Investigational Site
  • Dammam, Saudi Arabia, 32236
    • Novo Nordisk Investigational Site
  • Dammam, Saudi Arabia, 32253
    • Novo Nordisk Investigational Site
  • Dammam, Saudi Arabia, 32263
    • Novo Nordisk Investigational Site
  • Ihsa, Saudi Arabia, 36364
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia, 22252
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia, 23216
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia, 23521
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia, 22231
    • Novo Nordisk Investigational Site
  • Jeddah, Saudi Arabia, 22324,
    • Novo Nordisk Investigational Site
  • Makkah, Saudi Arabia, 24243
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 12625
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 12311
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 14611
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 11525
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 12381
    • Novo Nordisk Investigational Site
  • Riyadh, Saudi Arabia, 14212
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tresiba®; Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.	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.; Other Names: Tresiba®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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
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
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: NN1250-4440; U1111-1208-5065 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No