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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Xultophy® (insulin degludec/liraglutide)

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47354
    • Novo Nordisk Investigational Site
  • Busan, Korea, Republic of, 47392
    • Novo Nordisk Investigational Site
  • Busan, Korea, Republic of, 49267
    • Novo Nordisk Investigational Site
  • Daegu, Korea, Republic of, 42601
    • Novo Nordisk Investigational Site
  • Daejeon, Korea, Republic of, 302-120
    • Novo Nordisk Investigational Site
  • Daejeon, Korea, Republic of, 35220
    • Novo Nordisk Investigational Site
  • Daejeon, Korea, Republic of, 361-711
    • Novo Nordisk Investigational Site
  • Goyang, Korea, Republic of, 10326
    • Novo Nordisk Investigational Site
  • Gyeonggi-do, Korea, Republic of, 13620
    • Novo Nordisk Investigational Site
  • Gyeonggi-do, Korea, Republic of, 14754
    • Novo Nordisk Investigational Site
  • Gyeonggi-do, Korea, Republic of, 16499
    • Novo Nordisk Investigational Site
  • Gyeongsangnam-do, Korea, Republic of, 52727
    • Novo Nordisk Investigational Site
  • Hwasung-si, Korea, Republic of, 18450
    • Novo Nordisk Investigational Site
  • Incheon, Korea, Republic of, 22332
    • Novo Nordisk Investigational Site
  • Jeonju, Korea, Republic of, 561-712
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 01450
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 04058
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 130711
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 06591
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 04551
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 01830
    • Novo Nordisk Investigational Site
  • Uijeongbu, Korea, Republic of, 11759
    • Novo Nordisk Investigational Site
  • Ulsan, Korea, Republic of, 682-060
    • Novo Nordisk Investigational Site
  • Ulsan, Korea, Republic of, 44686
    • Novo Nordisk Investigational Site
  • Cheongsa-ro, Seo-gu
    • Daejeon, Cheongsa-ro, Seo-gu, Korea, Republic of, 35220
      • Novo Nordisk Investigational Site
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs) by preferred term	Count of events	baseline (Visit1, 0 week) to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in body weight	Kilograms	Visit 1 (0 week), Visit 3 (13 weeks)
Change in body weight	kilograms	Visit 1 (0 week), Visit 4 (26 weeks)
Change of Xultophy® dose	Units	Visit 1 (0 week), 13 weeks (Visit 3)
Change of Xultophy® dose	Units	Visit (0 week), Visit 4 (26 weeks)
Change in Glycosylated Haemoglobin (HbA1c)	Percentage	Visit 1 (0 week), Visit 3 (13 weeks)
Change in HbA1c	Percentage	Visit 1 (0 week), Visit 4 (26 weeks)
Individuals achieving HbA1c target less than 7.0 %	Percentage	Visit 1 (0 week), Visit 3 (13 weeks)
Individuals achieving HbA1c target less than 7.0 %	Percentage	Visit 1 (0 week), Visit 4 (26 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)	mg/dl	Visit 1 (0 week), Visit 3 (13 weeks)
Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)	mg/dl	Visit 1 (0 week), Visit 4 (26 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)	mg/dl	Visit 1 (0 week), Visit 3 (13 weeks)
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)	mg/dl	Visit 1 (0 week), Visit 3 (26 weeks)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 1452, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Xultophy
• Other Study ID Numbers: NN9068-4445; 1111-1211-7084 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No