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Real-World check: is xultophy safe and effective for diabetes?

NCT ID NCT04952779

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how safe and effective Xultophy (a combination of two diabetes drugs) is for adults with type 2 diabetes when used in everyday medical practice in Korea. About 750 people took part, and the study lasted 26 weeks. The goal was to track side effects and measure changes in blood sugar control and body weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xultophy (a combination of insulin degludec and liraglutide)
What this could lead to
If successful, this study will confirm that Xultophy is safe and works well for managing type 2 diabetes in real-world settings, supporting its continued use.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only looks at short-term use (26 weeks) and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

750 people

The number who actually took part.

Started

Jun 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea.

Ages

19 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Ajou University Hospital

    Gyeonggi-do, 16499, South Korea

  • Chungbuk National University Hospital

    Daejeon, 361-711, South Korea

  • Daejeon Endo Internal Medicine Clinic

    Daejeon, Cheongsa-ro, Seo-gu, 35220, South Korea

  • Daejeon Endo Internal Medicine Clinic

    Daejeon, 35220, South Korea

  • Dongguk University Ilsan Hospital

    Goyang, 10326, South Korea

  • Dongtan Jeil Women's Hospital

    Gyeonggi-do, 18450, South Korea

  • Eulji University Hospital_Daejeon

    Daejeon, 302-120, South Korea

  • Gyeongsang National University Hospital

    Gyeongsangnam-do, 52727, South Korea

  • Hanil General Hospital

    Seoul, 01450, South Korea

  • Hyewon Medical Foundation Sejong General Hospital

    Gyeonggi-do, 14754, South Korea

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Inje University Seoul Paik Hospital

    Seoul, 04551, South Korea

  • Isam Hospital

    Busan, 47354, South Korea

  • Jae Clinic

    Seoul, 08226, South Korea

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907, South Korea

  • KangNam Sacred Heart Hospital

    Seoul, 07441, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, 42601, South Korea

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278, South Korea

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830, South Korea

  • Sahm Yook Medical Center

    Seoul, 02500, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591, South Korea

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul, 07345, South Korea

  • Uijeongbu Eulji university Hospital

    Uijeongbu-si, 11759, South Korea

  • Ulsan Hospital

    Ulsan, 44686, South Korea

  • Ulsan University Hospital

    Ulsan, 682-060, South Korea

  • Yonsei Leehyunchul Internal Medicine

    Seoul, 04058, South Korea

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