DiabetesNCT02779413
A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea
An observational study of Diabetes, run by Novo Nordisk A/S at 44 sites in South Korea.
Trial summary
This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Diabetes
- What is being tested?
- insulin degludec
- How many people
- 3,303 participants
- Where
- 44 sitesSouth Korea
- Study dates
- 2 Jun 2016to 24 Jun 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus requiring insulin therapy for whom it has been decided to start with Tresiba® FlexTouch® based on the clinical judgment by their treating physician will be enrolled during enrolment period
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® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
South Korea44 sites
Novo Nordisk Investigational Site
Bucheon-si, 14647
Novo Nordisk Investigational Site
Busan, 47227
Novo Nordisk Investigational Site
Busan, 47392
Novo Nordisk Investigational Site
Busan, 49241
Novo Nordisk Investigational Site
Busan, 49267
Novo Nordisk Investigational Site
Busan
Novo Nordisk Investigational Site
Chungcheongnam-do
Novo Nordisk Investigational Site
Daegu, 41199
Novo Nordisk Investigational Site
Daegu
Novo Nordisk Investigational Site
Daejeon, 302-718
Novo Nordisk Investigational Site
Daejeon, 361-711
Novo Nordisk Investigational Site
Gangwon-do, 24253
Novo Nordisk Investigational Site
Gangwon-do, 25440
Novo Nordisk Investigational Site
Gangwon-do, 26426
Novo Nordisk Investigational Site
Gyeonggi-do, 10475
Novo Nordisk Investigational Site
Gyeonggi-do, 14754
Novo Nordisk Investigational Site
Gyeonggi-do
Novo Nordisk Investigational Site
Gyeongsangbuk-do, 39295
Novo Nordisk Investigational Site
Gyeongsangbuk-do, 39371
Novo Nordisk Investigational Site
Gyeongsangnam-do
Novo Nordisk Investigational Site
Incheon, 21431
Novo Nordisk Investigational Site
Incheon, 22332
Novo Nordisk Investigational Site
Incheon, 405-220
Novo Nordisk Investigational Site
Jeonju, 54987
Novo Nordisk Investigational Site
Pyungchon-Dong 896, Dongan-Gu, 431-796
Novo Nordisk Investigational Site
Seongnam-si, 463-707
Novo Nordisk Investigational Site
Seoul, 03722
Novo Nordisk Investigational Site
Seoul, 04551
Novo Nordisk Investigational Site
Seoul, 04564
Novo Nordisk Investigational Site
Seoul, 05278
Novo Nordisk Investigational Site
Seoul, 06273
Novo Nordisk Investigational Site
Seoul, 06351
Novo Nordisk Investigational Site
Seoul, 06591
Novo Nordisk Investigational Site
Seoul, 07441
Novo Nordisk Investigational Site
Seoul, 138-736
Novo Nordisk Investigational Site
Seoul, 139-707
Novo Nordisk Investigational Site
Seoul, 139-827
Novo Nordisk Investigational Site
Seoul, 150-713
Novo Nordisk Investigational Site
Seoul
Novo Nordisk Investigational Site
Suwon, 16499
Novo Nordisk Investigational Site
Suwon-si, Gyeonggi-do, 16247
Novo Nordisk Investigational Site
Ulsan, 44455
Novo Nordisk Investigational Site
Ulsan, 682-060
Novo Nordisk Investigational Site
Wŏnju, 220-701
About this study
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea
This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.
- Conditions
- Diabetes
- Being tested
- insulin degludec
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludecDrug
Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec | Not described Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AE)
Measured: Week 13± 2 weeks
Number of Adverse Events (AE)
Measured: week 26± 2 weeks
Secondary outcomes (20)
Insulin dose changes
Measured: Week 0, Week 26
Change in HbA1c
Measured: Week 0, week 13, week 26
Percentage of patients achieving the target of HbA1c below 7.0%
Measured: At week 13
Percentage of patients achieving the target of HbA1c below 7.0%
Measured: At week 26
Change in fasting plasma glucose (FPG)
Measured: Week 0, week 13, week 26
Changes in postprandial plasma glucose (PPG)
Measured: Week 0, week 13, week 26
Number of Adverse reactions (AR)
Measured: Week 13± 2 weeks
Number of Adverse reactions (AR)
Measured: week 26± 2 weeks
Number of Serious AE
Measured: Week 13± 2 weeks
Number of Serious AE
Measured: week 26± 2 weeks
Number of Serious AR
Measured: Week 13± 2 weeks
Number of Serious AR
Measured: week 26± 2 weeks
Number of Unexpected AR
Measured: Week 13± 2 weeks
Number of Unexpected AR
Measured: week 26± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Measured: Week 13± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Measured: week 26± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Measured: Week 13± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Measured: week 26± 2 weeks
Weight gain
Measured: week 13 ± 2 weeks
Weight gain
Measured: week 26± 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start2 Jun 2016
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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 DiabetesStudies 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
- 3,303 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
- NCT02779413
- Sponsor's protocol ID
- NN1250-4110
- Other IDs
- U1111-1176-2287
- Status last verified
- Apr 2020
- First submitted
- 13 May 2016
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee BW, Ahn KJ, Cho HC, Lee EY, Min K, Dahaoui A, Jeong JS, Lim HJ, Jang HC. Safety and Clinical Outcomes of Insulin Degludec in Korean Patients with Diabetes in Real-World Practices: A Prospective, Observational Study. Diabetes Ther. 2023 Oct;14(10):1659-1672. doi: 10.1007/s13300-023-01448-8. Epub 2023 Jul 19.
PubMed 37468685
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea
- ClinicalTrials.gov ID
- NCT02779413
- Acronym / sponsor ID
- NN1250-4110
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,303 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 20 May 2016 (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 the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec | – | Drug: insulin degludec |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus requiring insulin therapy for whom it has been decided to start with Tresiba® FlexTouch® based on the clinical judgment by their treating physician will be enrolled during enrolment period
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 degludecPatients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician. | Drug | Insulin degludec |
Primary outcome
Number of Adverse Events (AE)
Time frame: Week 13± 2 weeks
Number of Adverse Events (AE)
Time frame: week 26± 2 weeks
20 secondary outcomes
Insulin dose changes
Time frame: Week 0, Week 26
Change in HbA1c
Time frame: Week 0, week 13, week 26
Percentage of patients achieving the target of HbA1c below 7.0%
Time frame: At week 13
Percentage of patients achieving the target of HbA1c below 7.0%
Time frame: At week 26
Change in fasting plasma glucose (FPG)
Time frame: Week 0, week 13, week 26
Changes in postprandial plasma glucose (PPG)
Time frame: Week 0, week 13, week 26
Number of Adverse reactions (AR)
Time frame: Week 13± 2 weeks
Number of Adverse reactions (AR)
Time frame: week 26± 2 weeks
Number of Serious AE
Time frame: Week 13± 2 weeks
Number of Serious AE
Time frame: week 26± 2 weeks
Number of Serious AR
Time frame: Week 13± 2 weeks
Number of Serious AR
Time frame: week 26± 2 weeks
Number of Unexpected AR
Time frame: Week 13± 2 weeks
Number of Unexpected AR
Time frame: week 26± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time frame: Week 13± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time frame: week 26± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time frame: Week 13± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time frame: week 26± 2 weeks
Weight gain
Time frame: week 13 ± 2 weeks
Weight gain
Time frame: week 26± 2 weeks
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 21 Apr 2020.
- Derived from this study: PubMed 37468685Lee BW, Ahn KJ, Cho HC, Lee EY, Min K, Dahaoui A, Jeong JS, Lim HJ, Jang HC. Safety and Clinical Outcomes of Insulin Degludec in Korean Patients with Diabetes in Real-World Practices: A Prospective, Observational Study. Diabetes Ther. 2023 Oct;14(10):1659-1672. doi: 10.1007/s13300-023-01448-8. Epub 2023 Jul 19.
- 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
44 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, run by Novo Nordisk A/S at 44 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in South Korea. 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?
Number of Adverse Events (AE) (time frame: Week 13± 2 weeks). 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 NCT02779413, 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 21 Apr 2020.