Diabetes Mellitus, Type 2NCT04656106
A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in South Korea.
Trial summary
This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ryzodeg®
- How many people
- 200 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 27 Apr 2021to 1 Jul 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.
Who may be able to join
- Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
- Type 2 diabetes mellitus patients
- Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
- Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
- At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
- Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c [Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation]
- The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.
Who cannot join
- Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
- Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
- Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
- Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
- Pregnancy patient
- Patients not treated with the local licensed Ryzodeg®
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Novo Nordisk Investigational Site
Daejeon, 330-721
Novo Nordisk Investigational Site
Daejeon, 361-711
Novo Nordisk Investigational Site
Seongnam-si, 463-707
Novo Nordisk Investigational Site
Seoul, 03181
Novo Nordisk Investigational Site
Seoul, 06273
Novo Nordisk Investigational Site
Suwon-si, Gyeonggi-do, 16247
About this study
Official title: A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ryzodeg®
- 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.
Ryzodeg®Drug
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Ryzodeg | Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®. Receives: Drug: Ryzodeg® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (Glycosylated Hemoglobin)
Percentage point
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Secondary outcomes (11)
Patients with HbA1c less than 7.0 percentage (Yes or No)
Percentage of patients
Measured: At baseline (week 0)
Patients with HbA1c less than 7.0 percentage (Yes or No)
Percentage of patients
Measured: End of study (week 26)
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
Percentage of patients
Measured: At baseline (week 0)
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
Percentage of patients
Measured: End of study (week 26)
Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
Number of events
Measured: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
Number of events
Measured: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Change in FPG (Fasting Plasma Glucose)
mmol/L
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily total insulin dose
Unit/day
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily basal insulin dose
Unit/day
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily prandial insulin dose
Unit/day
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in body weight
Kg
Measured: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start27 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656106
- Sponsor's protocol ID
- NN5401-4653
- Other IDs
- U1111-1257-2534
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2020
- Last updated
- 28 Sep 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
Kang S, Ahn YB, Oh TK, Lee WY, Chun SW, Bae B, Dahaoui A, Jeong JS, Jung S, Jang HC. Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus. Diabetes Metab J. 2024 Sep;48(5):929-936. doi: 10.4093/dmj.2023.0297. Epub 2024 Feb 27.
PubMed 38410023
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
- ClinicalTrials.gov ID
- NCT04656106
- Acronym / sponsor ID
- NN5401-4653
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Dec 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.
This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).
All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ryzodeg | – | Drug: Ryzodeg®Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.
Key inclusion criteria (7 listed)
- Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation
- Type 2 diabetes mellitus patients
- Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®
- Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)
- At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation
Key exclusion criteria (6 listed)
- Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®
- Patients switching to Ryzodeg® below 26 weeks prior to the data collection date
- Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®
- Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®
- Pregnancy patient
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 |
|---|---|---|
| Ryzodeg®All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter. | Drug | Ryzodeg |
Primary outcome
Change in HbA1c (Glycosylated Hemoglobin)
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Percentage point
11 secondary outcomes
Patients with HbA1c less than 7.0 percentage (Yes or No)
Time frame: At baseline (week 0)
Patients with HbA1c less than 7.0 percentage (Yes or No)
Time frame: End of study (week 26)
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
Time frame: At baseline (week 0)
Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)
Time frame: End of study (week 26)
Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
Time frame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®
Time frame: Period 1(week-26 to week 0), Period 2(week 0 to week 26)
Change in FPG (Fasting Plasma Glucose)
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily total insulin dose
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily basal insulin dose
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in daily prandial insulin dose
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)
Change in body weight
Time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to 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 28 Sep 2021.
- Derived from this study: PubMed 38410023Kang S, Ahn YB, Oh TK, Lee WY, Chun SW, Bae B, Dahaoui A, Jeong JS, Jung S, Jang HC. Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus. Diabetes Metab J. 2024 Sep;48(5):929-936. doi: 10.4093/dmj.2023.0297. Epub 2024 Feb 27.
- 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 transparency (dept. 1452) study director
Novo Nordisk A/S
6 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 6 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?
The sponsor lists 7 inclusion and 6 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Change in HbA1c (Glycosylated Hemoglobin) (time frame: Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)). 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 NCT04656106, 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 28 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.