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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04952779
• Other study ID #: NN9068-4445
• Secondary ID: 1111-1211-7084
• Status: Enrolling by invitation
• Start date: June 2, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 750
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Cheonan	Chungcheongnam-do
Korea, Republic of	Novo Nordisk Investigational Site	Daegu
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon	Cheongsa-ro, Seo-gu
Korea, Republic of	Novo Nordisk Investigational Site	Goyang
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeongsangnam-do
Korea, Republic of	Novo Nordisk Investigational Site	Hwasung-si
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Jeonju
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Uijeongbu
Korea, Republic of	Novo Nordisk Investigational Site	Ulsan
Korea, Republic of	Novo Nordisk Investigational Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) by preferred term	Count of events	baseline (Visit1, 0 week) to 26 weeks
Secondary	Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia	Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)	Visit1 (0 week) to 26 weeks
Secondary	Change in body weight	Kilograms	Visit 1 (0 week), Visit 3 (13 weeks)
Secondary	Change in body weight	kilograms	Visit 1 (0 week), Visit 4 (26 weeks)
Secondary	Change of Xultophy® dose	Units	Visit 1 (0 week), 13 weeks (Visit 3)
Secondary	Change of Xultophy® dose	Units	Visit (0 week), Visit 4 (26 weeks)
Secondary	Change in Glycosylated Haemoglobin (HbA1c)	Percentage	Visit 1 (0 week), Visit 3 (13 weeks)
Secondary	Change in HbA1c	Percentage	Visit 1 (0 week), Visit 4 (26 weeks)
Secondary	Individuals achieving HbA1c target less than 7.0 %	Percentage	Visit 1 (0 week), Visit 3 (13 weeks)
Secondary	Individuals achieving HbA1c target less than 7.0 %	Percentage	Visit 1 (0 week), Visit 4 (26 weeks)
Secondary	Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)	mg/dl	Visit 1 (0 week), Visit 3 (13 weeks)
Secondary	Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)	mg/dl	Visit 1 (0 week), Visit 4 (26 weeks)
Secondary	Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)	mg/dl	Visit 1 (0 week), Visit 3 (13 weeks)
Secondary	Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)	mg/dl	Visit 1 (0 week), Visit 3 (26 weeks)