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

NCT04952779 | Completed

• 2 other identifiers: NN9068-44451111-1211-7084
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 32

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs) by preferred term

  Count of events

  baseline (Visit1, 0 week) to 26 weeks

Secondary Outcomes (13)

• Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia

  Visit1 (0 week) to 26 weeks

• Change in body weight

  Visit 1 (0 week), Visit 3 (13 weeks)

• Change in body weight

  Visit 1 (0 week), Visit 4 (26 weeks)

• Change of Xultophy® dose

  Visit 1 (0 week), 13 weeks (Visit 3)

• Change of Xultophy® dose

  Visit (0 week), Visit 4 (26 weeks)

Study Arms (1)

Xultophy®

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

Drug: Xultophy® (insulin degludec/liraglutide)

Interventions

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.

Also known as: insulin degludec/liraglutide

Xultophy®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (32)

Daejeon Endo Internal Medicine Clinic

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

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

Seoul National University Bundang Hospital

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

Location

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

Suwon, Gyeonggi-do, 16247, South Korea

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Isam Hospital

Busan, 47354, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Eulji University Hospital_Daejeon

Daejeon, 302-120, South Korea

Location

Daejeon Endo Internal Medicine Clinic

Daejeon, 35220, South Korea

Location

Chungbuk National University Hospital

Daejeon, 361-711, South Korea

Location

Dongguk University Ilsan Hospital

Goyang, 10326, South Korea

Location

Hyewon Medical Foundation Sejong General Hospital

Gyeonggi-do, 14754, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 16499, South Korea

Location

Dongtan Jeil Women's Hospital

Gyeonggi-do, 18450, South Korea

Location

Gyeongsang National University Hospital

Gyeongsangnam-do, 52727, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Hanil General Hospital

Seoul, 01450, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Sahm Yook Medical Center

Seoul, 02500, South Korea

Location

Yonsei Leehyunchul Internal Medicine

Seoul, 04058, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, 04551, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

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

Seoul, 06591, South Korea

Location

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

Seoul, 07345, South Korea

Location

KangNam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Jae Clinic

Seoul, 08226, South Korea

Location

Uijeongbu Eulji university Hospital

Uijeongbu-si, 11759, South Korea

Location

Ulsan Hospital

Ulsan, 44686, South Korea

Location

Ulsan University Hospital

Ulsan, 682-060, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Xultophy; insulin degludec; Liraglutide; IDegLira

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency dept. 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: June 2, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (32)