Diabetes Mellitus, Type 2UPDATESNCT03785522
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 21 sites in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin degludec
- How many people
- 597 participants
- Where
- 21 sitesSaudi Arabia
- Study dates
- 23 Dec 2018to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes in Saudi Arabia treated with any antihyperglycaemic medication(s), except Tresiba®, are eligible for this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Saudi Arabia21 sites
Novo Nordisk Investigational Site
AL Qateef, 31911
Novo Nordisk Investigational Site
Dammam, 32236
Novo Nordisk Investigational Site
Dammam, 32253
Novo Nordisk Investigational Site
Dammam, 32263
Novo Nordisk Investigational Site
Ihsa, 36364
Novo Nordisk Investigational Site
Jeddah, 22231
Novo Nordisk Investigational Site
Jeddah, 22252
Novo Nordisk Investigational Site
Jeddah, 22324,
Novo Nordisk Investigational Site
Jeddah, 23216
Novo Nordisk Investigational Site
Jeddah, 23521
Novo Nordisk Investigational Site
Jeddah
Novo Nordisk Investigational Site
Jubail, 35718
Novo Nordisk Investigational Site
Khobar, 34234
Novo Nordisk Investigational Site
Khobar, 34425
Novo Nordisk Investigational Site
Mecca, 24243
Novo Nordisk Investigational Site
Riyadh, 11525
Novo Nordisk Investigational Site
Riyadh, 12311
Novo Nordisk Investigational Site
Riyadh, 12381
Novo Nordisk Investigational Site
Riyadh, 12625
Novo Nordisk Investigational Site
Riyadh, 14212
Novo Nordisk Investigational Site
Riyadh, 14611
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin degludec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin degludecDrug
Also called Tresiba®
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.
| Study group | Role | What they receive |
|---|---|---|
| Tresiba® | Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks. Receives: Drug: Insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0 (baseline), Week 26 (end of study)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"?
Measured: 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.
Measured: 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.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start23 Dec 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785522
- Sponsor's protocol ID
- NN1250-4440
- Other IDs
- U1111-1208-5065
- Acronym
- UPDATES
- Status last verified
- Jun 2021
- First submitted
- 20 Dec 2018
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 36417058
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia
- ClinicalTrials.gov ID
- NCT03785522
- Acronym / sponsor ID
- UPDATES / NN1250-4440
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tresiba® | – | Drug: Insulin degludecPatients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes in Saudi Arabia treated with any antihyperglycaemic medication(s), except Tresiba®, are eligible for this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin degludecAlso: Tresiba®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. | Drug | Tresiba® |
Primary outcome
Change in glycated haemoglobin (HbA1c) (percentage)
Time frame: 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.
Change in HbA1c (mmol/mol)
Time frame: 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.
9 secondary outcomes
Change in fasting plasma glucose (FPG) (mg/dL)
Time frame: Week 0 (baseline), Week 26 (end of study)
Change in FPG (mmol/L)
Time frame: Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Basal insulin
Time frame: Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Prandial insulin
Time frame: Week 0 (baseline), Week 26 (end of study)
Change in daily insulin doses: Total insulin
Time frame: Week 0 (baseline), Week 26 (end of study)
Change in number of patient reported overall non-severe hypoglycaemic episodes
Time frame: Week -4 to 0, week 22 to 26
Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
Time frame: Week -4 to 0, week 22 to 26
Change in number of patient reported severe hypoglycaemic episodes (overall)
Time frame: Week -26 to 0, week 0 to 26
Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable
Time frame: Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 36417058AlMalki 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 21 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (percentage) (time frame: Week 0 (baseline), Week 26 (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785522, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.