Diabetes Mellitus, Type 2NCT04952779
Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 32 sites in South Korea.
Trial summary
The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks. 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?
- Xultophy® (insulin degludec/liraglutide)
- How many people
- 750 participants
- Where
- 32 sitesSouth Korea
- Study dates
- 2 Jun 2021to 15 Dec 2024
- 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: Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.
Who may be able to join
- The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
- Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age 19 years or older at the time of signing informed consent form.
- Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).
Who cannot join
- Participants who are or have previously been on Xultophy® therapy.
- Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
South Korea32 sites
Isam Hospital
Busan, 47354
Inje University Busan Paik Hospital
Busan, 47392
Kosin University Gospel Hospital
Busan, 49267
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 31151
Keimyung University Dongsan Hospital
Daegu, 42601
Keimyung University Dongsan Medical Center
Daegu, 42601
Daejeon Endo Internal Medicine Clinic
Daejeon, Cheongsa-ro, Seo-gu, 35220
Eulji University Hospital_Daejeon
Daejeon, 302-120
Daejeon Endo Internal Medicine Clinic
Daejeon, 35220
Chungbuk National University Hospital
Daejeon, 361-711
Dongguk University Ilsan Hospital
Goyang, 10326
Hyewon Medical Foundation Sejong General Hospital
Gyeonggi-do, 14754
Ajou University Hospital
Gyeonggi-do, 16499
Dongtan Jeil Women's Hospital
Gyeonggi-do, 18450
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727
Inha University Hospital
Incheon, 22332
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Hanil General Hospital
Seoul, 01450
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Sahm Yook Medical Center
Seoul, 02500
Yonsei Leehyunchul Internal Medicine
Seoul, 04058
Inje University Seoul Paik Hospital
Seoul, 04551
Kyung Hee University Hospital at Gangdong
Seoul, 05278
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, 07345
KangNam Sacred Heart Hospital
Seoul, 07441
Jae Clinic
Seoul, 08226
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Uijeongbu Eulji university Hospital
Uijeongbu-si, 11759
Ulsan Hospital
Ulsan, 44686
Ulsan University Hospital
Ulsan, 682-060
About this study
Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Xultophy® (insulin degludec/liraglutide)
- 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.
Xultophy® (insulin degludec/liraglutide)Drug
Also called insulin degludec/liraglutide
Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin.
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS.
The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study.
| Study group | Role | What they receive |
|---|---|---|
| Xultophy® | Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. Receives: Drug: Xultophy® (insulin degludec/liraglutide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) by preferred term
Count of events
Measured: baseline (Visit1, 0 week) to 26 weeks
Secondary outcomes (13)
Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia
Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)
Measured: Visit1 (0 week) to 26 weeks
Change in body weight
Kilograms
Measured: Visit 1 (0 week), Visit 3 (13 weeks)
Change in body weight
kilograms
Measured: Visit 1 (0 week), Visit 4 (26 weeks)
Change of Xultophy® dose
Units
Measured: Visit 1 (0 week), 13 weeks (Visit 3)
Change of Xultophy® dose
Units
Measured: Visit (0 week), Visit 4 (26 weeks)
Change in Glycosylated Haemoglobin (HbA1c)
Percentage
Measured: Visit 1 (0 week), Visit 3 (13 weeks)
Change in HbA1c
Percentage
Measured: Visit 1 (0 week), Visit 4 (26 weeks)
Individuals achieving HbA1c target less than 7.0 %
Percentage
Measured: Visit 1 (0 week), Visit 3 (13 weeks)
Individuals achieving HbA1c target less than 7.0 %
Percentage
Measured: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
mg/dl
Measured: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
mg/dl
Measured: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
mg/dl
Measured: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
mg/dl
Measured: Visit 1 (0 week), Visit 3 (26 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start2 Jun 2021
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
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
- 750 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
- NCT04952779
- Sponsor's protocol ID
- NN9068-4445
- Other IDs
- 1111-1211-7084
- Status last verified
- Dec 2025
- First submitted
- 28 Jun 2021
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. 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 Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
- ClinicalTrials.gov ID
- NCT04952779
- Acronym / sponsor ID
- NN9068-4445
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 7 Jul 2021 (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 aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xultophy® | – | Drug: Xultophy® (insulin degludec/liraglutide)Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.
Key inclusion criteria (4 listed)
- The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study.
- Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age 19 years or older at the time of signing informed consent form.
- Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label).
Key exclusion criteria (4 listed)
- Participants who are or have previously been on Xultophy® therapy.
- Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients).
- 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.
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 |
|---|---|---|
| Xultophy® (insulin degludec/liraglutide)Also: insulin degludec/liraglutideXultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin. Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study. | Drug | Xultophy® |
Primary outcome
Incidence of Adverse Events (AEs) by preferred term
Time frame: baseline (Visit1, 0 week) to 26 weeks
Count of events
13 secondary outcomes
Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia
Time frame: Visit1 (0 week) to 26 weeks
Change in body weight
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in body weight
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change of Xultophy® dose
Time frame: Visit 1 (0 week), 13 weeks (Visit 3)
Change of Xultophy® dose
Time frame: Visit (0 week), Visit 4 (26 weeks)
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in HbA1c
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Individuals achieving HbA1c target less than 7.0 %
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Individuals achieving HbA1c target less than 7.0 %
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)
Time frame: Visit 1 (0 week), Visit 4 (26 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
Time frame: Visit 1 (0 week), Visit 3 (13 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
Time frame: Visit 1 (0 week), Visit 3 (26 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 31 Dec 2025.
- 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
32 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 32 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 4 inclusion and 4 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Incidence of Adverse Events (AEs) by preferred term (time frame: baseline (Visit1, 0 week) to 26 weeks). 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 31 Dec 2025.