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Completed

NCT Number: NCT04952779

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daejeon Endo Internal Medicine Clinic, Daejeon, Cheongsa-ro, Seo-gu, South Korea

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xultophy® (insulin degludec/liraglutide)

Drug

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.

Other names: insulin degludec/liraglutide

Primary outcomes

  1. Incidence of Adverse Events (AEs) by preferred term

    Time frame: baseline (Visit1, 0 week) to 26 weeks

    Count of events

Secondary outcomes

  1. Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia

    Time frame: Visit1 (0 week) to 26 weeks

    Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)

  2. Change in body weight

    Time frame: Visit 1 (0 week), Visit 3 (13 weeks)

    Kilograms

  3. Change in body weight

    Time frame: Visit 1 (0 week), Visit 4 (26 weeks)

    kilograms

  4. Change of Xultophy® dose

    Time frame: Visit 1 (0 week), 13 weeks (Visit 3)

    Units

  5. Change of Xultophy® dose

    Time frame: Visit (0 week), Visit 4 (26 weeks)

    Units

  6. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Visit 1 (0 week), Visit 3 (13 weeks)

    Percentage

  7. Change in HbA1c

    Time frame: Visit 1 (0 week), Visit 4 (26 weeks)

    Percentage

  8. Individuals achieving HbA1c target less than 7.0 %

    Time frame: Visit 1 (0 week), Visit 3 (13 weeks)

    Percentage

  9. Individuals achieving HbA1c target less than 7.0 %

    Time frame: Visit 1 (0 week), Visit 4 (26 weeks)

    Percentage

  10. Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

    Time frame: Visit 1 (0 week), Visit 3 (13 weeks)

    mg/dl

  11. Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

    Time frame: Visit 1 (0 week), Visit 4 (26 weeks)

    mg/dl

  12. Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

    Time frame: Visit 1 (0 week), Visit 3 (13 weeks)

    mg/dl

  13. Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

    Time frame: Visit 1 (0 week), Visit 3 (26 weeks)

    mg/dl

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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