Diabetes Mellitus, Type 1NCT01984372
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin degludec
- How many people
- 6,163 participants
- Where
- 1 siteJapan
- Study dates
- 6 Nov 2013to 30 Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus requiring insulin therapy not previously treated with Tresiba®, including newly-diagnosed patients whom the physician has judged as appropriate to start treatment with Tresiba®.
Who may be able to join
- Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment
Who cannot join
- Patients who are or have previously been on Tresiba® therapy
- Patients who have previously been participating in this PMS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.
- Being tested
- insulin degludec
- Medical subject headings
- Diabetes Mellitus, Type 1, 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
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tresiba® users | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs (Adverse Events) by preferred term
Measured: During 3 years of treatment
Secondary outcomes (7)
Incidence of AEs (Adverse Events) by preferred term
Measured: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Measured: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Measured: During 3 years of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Measured: During 6 months of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Measured: During 3 years of treatment
Incidence of severe hypoglycaemia
Measured: During 6 months of treatment
Incidence of severe hypoglycaemia
Measured: During 3 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start6 Nov 2013
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 6,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984372
- Sponsor's protocol ID
- NN1250-4061
- Other IDs
- U1111-1144-4412
- Status last verified
- Aug 2020
- First submitted
- 7 Nov 2013
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
- ClinicalTrials.gov ID
- NCT01984372
- Acronym / sponsor ID
- NN1250-4061
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,163 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2013 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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.
This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tresiba® users | – | Drug: insulin degludec |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus requiring insulin therapy not previously treated with Tresiba®, including newly-diagnosed patients whom the physician has judged as appropriate to start treatment with Tresiba®.
Key inclusion criteria (1 listed)
- Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment
Key exclusion criteria (2 listed)
- Patients who are or have previously been on Tresiba® therapy
- Patients who have previously been participating in this PMS
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 degludecFrequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy. | Drug | Tresiba® users |
Primary outcome
Incidence of AEs (Adverse Events) by preferred term
Time frame: During 3 years of treatment
7 secondary outcomes
Incidence of AEs (Adverse Events) by preferred term
Time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
Time frame: During 3 years of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Time frame: During 6 months of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
Time frame: During 3 years of treatment
Incidence of severe hypoglycaemia
Time frame: During 6 months of treatment
Incidence of severe hypoglycaemia
Time frame: During 3 years of treatment
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 Aug 2020.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site 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 1 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
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 1 inclusion and 2 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Incidence of AEs (Adverse Events) by preferred term (time frame: During 3 years of treatment). 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 4 Aug 2020.