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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04952779

Collaborator

(none)

750

Enrollment

Locations

37.9

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Xultophy® (insulin degludec/liraglutide)

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Jun 2, 2021

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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) 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

Arm

Intervention/Treatment

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)

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

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events (AEs) by preferred term [baseline (Visit1, 0 week) to 26 weeks]
Count of events

Secondary Outcome Measures

Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia [Visit1 (0 week) to 26 weeks]
Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)
Change in body weight [Visit 1 (0 week), Visit 3 (13 weeks)]
Kilograms
Change in body weight [Visit 1 (0 week), Visit 4 (26 weeks)]
kilograms
Change of Xultophy® dose [Visit 1 (0 week), 13 weeks (Visit 3)]
Units
Change of Xultophy® dose [Visit (0 week), Visit 4 (26 weeks)]
Units
Change in Glycosylated Haemoglobin (HbA1c) [Visit 1 (0 week), Visit 3 (13 weeks)]
Percentage
Change in HbA1c [Visit 1 (0 week), Visit 4 (26 weeks)]
Percentage
Individuals achieving HbA1c target less than 7.0 % [Visit 1 (0 week), Visit 3 (13 weeks)]
Percentage
Individuals achieving HbA1c target less than 7.0 % [Visit 1 (0 week), Visit 4 (26 weeks)]
Percentage
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) [Visit 1 (0 week), Visit 3 (13 weeks)]
mg/dl
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) [Visit 1 (0 week), Visit 4 (26 weeks)]
mg/dl
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) [Visit 1 (0 week), Visit 3 (13 weeks)]
mg/dl
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) [Visit 1 (0 week), Visit 3 (26 weeks)]
mg/dl

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Daejeon	Cheongsa-ro, Seo-gu	Korea, Republic of	35220
2	Novo Nordisk Investigational Site	Busan		Korea, Republic of	47392
3	Novo Nordisk Investigational Site	Busan		Korea, Republic of	49267
4	Novo Nordisk Investigational Site	Daejeon		Korea, Republic of	302-120
5	Novo Nordisk Investigational Site	Goyang		Korea, Republic of	10326
6	Novo Nordisk Investigational Site	Gyeonggi-do		Korea, Republic of	13620
7	Novo Nordisk Investigational Site	Incheon		Korea, Republic of	22332
8	Novo Nordisk Investigational Site	Jeonju		Korea, Republic of	561-712
9	Novo Nordisk Investigational Site	Suwon		Korea, Republic of	16499
10	Novo Nordisk Investigational Site	Ulsan		Korea, Republic of	682-060