Diabetes Mellitus, Type 2NCT04315688
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 40 sites in Russia.
Trial summary
The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 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
- 494 participants
- Where
- 40 sitesRussia
- Study dates
- 30 Mar 2020to 2 Aug 2021
- 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
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 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 antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
- Available and documented HbA1c value 12 weeks or less 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
40 sites in 1 country.
40 sites in 1 country
Russia40 sites
Novo Nordisk Investigational Site
Alushta, 298500
Novo Nordisk Investigational Site
Belogorsk, 297600
Novo Nordisk Investigational Site
Bryansk, 242610
Novo Nordisk Investigational Site
Chapayevsk, 446100
Novo Nordisk Investigational Site
Chelyabinsk, 454048
Novo Nordisk Investigational Site
Dyurtyuli, 452320
Novo Nordisk Investigational Site
Elista, 358000
Novo Nordisk Investigational Site
Ivanovo, 153012
Novo Nordisk Investigational Site
Kaluga, 248002
Novo Nordisk Investigational Site
Kazan', 420073
Novo Nordisk Investigational Site
Krasnodar, 350000
Novo Nordisk Investigational Site
Krasnoyarsk, 660021
Novo Nordisk Investigational Site
Krasnoyarsk, 660062
Novo Nordisk Investigational Site
Lipetsk, 398043
Novo Nordisk Investigational Site
Lyskovo, 606210
Novo Nordisk Investigational Site
Magnitogorsk, 455016
Novo Nordisk Investigational Site
Moscow, 111401
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 129226
Novo Nordisk Investigational Site
Moscow Region, Dolgoprudny, 141707
Novo Nordisk Investigational Site
Nizhny Novgorod, 603155
Novo Nordisk Investigational Site
Odintsovo, Moscow Region, 143003
Novo Nordisk Investigational Site
Penza, 440039
Novo Nordisk Investigational Site
Penza, 440066
Novo Nordisk Investigational Site
Rostov-on-Don, 344004
Novo Nordisk Investigational Site
Saint Petersburg, 193231
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Saint-Peterburg, 195256
Novo Nordisk Investigational Site
Saint-Peterburg, 199004
Novo Nordisk Investigational Site
Samara, 443111
Novo Nordisk Investigational Site
Saratov, 410005
Novo Nordisk Investigational Site
Saratov, 410033
Novo Nordisk Investigational Site
Sergiyev Posad, 141300
Novo Nordisk Investigational Site
Sevastopol’, 299011
Novo Nordisk Investigational Site
Sovetskiy, 297200
Novo Nordisk Investigational Site
Syktyvkar, 167981
Novo Nordisk Investigational Site
Tula, 300035
Novo Nordisk Investigational Site
Ufa, 450038
Novo Nordisk Investigational Site
Voskresensk, 140203
Novo Nordisk Investigational Site
Vyksa, 607060
About this study
Official title: A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia
The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal 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
Treatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the study.
| Study group | Role | What they receive |
|---|---|---|
| Tresiba® | Patients with type 2 diabetes Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in laboratory measured glycated haemoglobin (HbA1c) (% point)
% point
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured HbA1c (mmol/mol)
mmol/mol
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Secondary outcomes (9)
Change in laboratory measured fasting plasma glucose (FPG)
mg/dL
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured FPG
mmol/L
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (basal insulin)
units/day
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (prandial insulin)
units/day
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (total insulin)
units/day
Measured: From baseline (week -12 to 0) to end of study (week 26-36)
Change in number of patient reported overall non-severe hypoglycaemic episodes
Number of episodes
Measured: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
Number of episodes
Measured: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Change in number of patient reported severe hypoglycaemic episodes (overall)
Number of episodes
Measured: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)
Number of participants per response option
Measured: After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start30 Mar 2020
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 494 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
- NCT04315688
- Sponsor's protocol ID
- NN1250-4589
- Other IDs
- U1111-1236-4887
- Status last verified
- Aug 2021
- First submitted
- 17 Mar 2020
- Last updated
- 23 Aug 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 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 Russia
- ClinicalTrials.gov ID
- NCT04315688
- Acronym / sponsor ID
- NN1250-4589
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 19 Mar 2020 (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 with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal 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 |
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
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 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 antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1).
- Available and documented HbA1c value 12 weeks or less 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 degludecTreatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the study. | Drug | Tresiba® |
Primary outcome
Change in laboratory measured glycated haemoglobin (HbA1c) (% point)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
% point
Change in laboratory measured HbA1c (mmol/mol)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
mmol/mol
9 secondary outcomes
Change in laboratory measured fasting plasma glucose (FPG)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
Change in laboratory measured FPG
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (basal insulin)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (prandial insulin)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
Change in daily insulin doses (total insulin)
Time frame: From baseline (week -12 to 0) to end of study (week 26-36)
Change in number of patient reported overall non-severe hypoglycaemic episodes
Time frame: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
Time frame: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Change in number of patient reported severe hypoglycaemic episodes (overall)
Time frame: Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36)
Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options)
Time frame: After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36)
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 23 Aug 2021.
- 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
40 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 40 sites in Russia.
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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Russia. 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 laboratory measured glycated haemoglobin (HbA1c) (% point) (time frame: From baseline (week -12 to 0) to end of study (week 26-36)). 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?
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 23 Aug 2021.