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NCT04952779·Not applicable·OBSERVATIONAL

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

LiraglutideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

750

Locations

32

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Xultophy® (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.

Timeline

From registration to results.

  1. First posted

    Jul 7, 2021

  2. Study start

    Jun 2, 2021

  3. Primary completion

    Dec 15, 2024

  4. Study completion

    Dec 15, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 31, 2025

Outcomes

What the study measures.

Primary outcomes

Incidence of Adverse Events (AEs) by preferred term

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

Count of events

Secondary outcomes

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)

Change in body weight

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

Kilograms

Change in body weight

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

kilograms

Change of Xultophy® dose

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

Units

Change of Xultophy® dose

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

Units

Change in Glycosylated Haemoglobin (HbA1c)

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

Percentage

Change in HbA1c

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

Percentage

Individuals achieving HbA1c target less than 7.0 %

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

Percentage

Individuals achieving HbA1c target less than 7.0 %

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

Percentage

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

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

mg/dl

Eligibility

Who can take part.

Minimum age
19 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Not reported

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.

Study locations

32 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

Daejeon Endo Internal Medicine Clinic

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

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

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

Suwon, Gyeonggi-do, South Korea

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Isam Hospital

Busan, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Eulji University Hospital_Daejeon

Daejeon, South Korea

Daejeon Endo Internal Medicine Clinic

Daejeon, South Korea

Chungbuk National University Hospital

Daejeon, South Korea

Dongguk University Ilsan Hospital

Goyang, South Korea

Hyewon Medical Foundation Sejong General Hospital

Gyeonggi-do, South Korea

Ajou University Hospital

Gyeonggi-do, South Korea

Dongtan Jeil Women's Hospital

Gyeonggi-do, South Korea

Gyeongsang National University Hospital

Gyeongsangnam-do, South Korea

Inha University Hospital

Incheon, South Korea

Hanil General Hospital

Seoul, South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Sahm Yook Medical Center

Seoul, South Korea

Yonsei Leehyunchul Internal Medicine

Seoul, South Korea

Inje University Seoul Paik Hospital

Seoul, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

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