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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Xultophy®

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

Xultophy® (insulin degludec/liraglutide)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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insulin degludec/liraglutide

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 1452

Role: STUDY_DIRECTOR

Novo Nordisk A/S

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South Korea

Other Identifiers

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1111-1211-7084

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4445

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Xultophy®

Xultophy® (insulin degludec/liraglutide)

Interventions

Xultophy® (insulin degludec/liraglutide)

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novo Nordisk A/S

Responsible Party

Principal Investigators

Clinical Transparency dept. 1452

Locations

Daejeon Endo Internal Medicine Clinic

Soon Chun Hyang University Hospital Cheonan

Seoul National University Bundang Hospital

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

Jeonbuk National University Hospital

Isam Hospital

Inje University Busan Paik Hospital

Kosin University Gospel Hospital

Keimyung University Dongsan Hospital

Keimyung University Dongsan Medical Center

Eulji University Hospital_Daejeon

Daejeon Endo Internal Medicine Clinic

Chungbuk National University Hospital

Dongguk University Ilsan Hospital

Hyewon Medical Foundation Sejong General Hospital

Ajou University Hospital

Dongtan Jeil Women's Hospital

Gyeongsang National University Hospital

Inha University Hospital

Hanil General Hospital

Nowon Eulji Medical Center, Eulji University

Sahm Yook Medical Center

Yonsei Leehyunchul Internal Medicine

Inje University Seoul Paik Hospital

Kyung Hee University Hospital at Gangdong

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

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

KangNam Sacred Heart Hospital

Jae Clinic

Uijeongbu Eulji university Hospital

Ulsan Hospital

Ulsan University Hospital

Countries

Other Identifiers

1111-1211-7084

NN9068-4445