## Protocol Section
### Identification Module
**NCT ID:** NCT04952779

**Brief Title:** 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

**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

#### Organization Study ID Info
**ID:** NN9068-4445
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**Domain:** World Health Organization
**ID:** 1111-1211-7084
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-07

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-06-02

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2021-07-07
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-28
**Study First Submit QC Date:** 2021-06-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 750

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Xultophy® (insulin degludec/liraglutide)

**Label:** Xultophy®

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Xultophy®

**Description:** 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.

**Name:** Xultophy® (insulin degludec/liraglutide)

**Other Names:**

- insulin degludec/liraglutide

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Count of events

**Measure:** Incidence of Adverse Events (AEs) by preferred term

**Time Frame:** baseline (Visit1, 0 week) to 26 weeks

#### Secondary Outcomes

**Description:** Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L)

**Measure:** Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia

**Time Frame:** Visit1 (0 week) to 26 weeks

**Description:** Kilograms

**Measure:** Change in body weight

**Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks)

**Description:** kilograms

**Measure:** Change in body weight

**Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks)

**Description:** Units

**Measure:** Change of Xultophy® dose

**Time Frame:** Visit 1 (0 week), 13 weeks (Visit 3)

**Description:** Units

**Measure:** Change of Xultophy® dose

**Time Frame:** Visit (0 week), Visit 4 (26 weeks)

**Description:** Percentage

**Measure:** Change in Glycosylated Haemoglobin (HbA1c)

**Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks)

**Description:** Percentage

**Measure:** Change in HbA1c

**Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks)

**Description:** Percentage

**Measure:** Individuals achieving HbA1c target less than 7.0 %

**Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks)

**Description:** Percentage

**Measure:** Individuals achieving HbA1c target less than 7.0 %

**Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks)

**Description:** mg/dl

**Measure:** Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

**Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks)

**Description:** mg/dl

**Measure:** Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG)

**Time Frame:** Visit 1 (0 week), Visit 4 (26 weeks)

**Description:** mg/dl

**Measure:** Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

**Time Frame:** Visit 1 (0 week), Visit 3 (13 weeks)

**Description:** mg/dl

**Measure:** Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)

**Time Frame:** Visit 1 (0 week), Visit 3 (26 weeks)

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**State:** Cheongsa-ro, Seo-gu

**Zip:** 35220

**Location 2:**

**City:** Cheonan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**State:** Chungcheongnam-do

**Zip:** 31151

**Location 3:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 47354

**Location 4:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 47392

**Location 5:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 49267

**Location 6:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 42601

**Location 7:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 302-120

**Location 8:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 35220

**Location 9:**

**City:** Daejeon

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 361-711

**Location 10:**

**City:** Goyang

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 10326

**Location 11:**

**City:** Gyeonggi-do

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 13620

**Location 12:**

**City:** Gyeonggi-do

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 14754

**Location 13:**

**City:** Gyeonggi-do

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 16499

**Location 14:**

**City:** Gyeongsangnam-do

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 52727

**Location 15:**

**City:** Hwasung-si

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 18450

**Location 16:**

**City:** Incheon

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 22332

**Location 17:**

**City:** Jeonju

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 561-712

**Location 18:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 01450

**Location 19:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 01830

**Location 20:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 04058

**Location 21:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 04551

**Location 22:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 06591

**Location 23:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 130711

**Location 24:**

**City:** Uijeongbu

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 11759

**Location 25:**

**City:** Ulsan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 44686

**Location 26:**

**City:** Ulsan

**Country:** Korea, Republic of

**Facility:** Novo Nordisk Investigational Site

**Zip:** 682-060

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Clinical Transparency dept. 1452

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

**IPD Sharing:** YES

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000054795

- Term: Incretins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Day 1

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: HIGH

- As Found: Day 1

- ID: M267475

- Name: Xultophy

- Relevance: HIGH

- As Found: Absolute Bioavailability

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M419

- Name: Liraglutide

- Relevance: HIGH

- As Found: Ascending

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M26073

- Name: Insulin, Long-Acting

- Relevance: HIGH

- As Found: Ligament

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

- ID: C000557859

- Term: Insulin, Globin Zinc

- ID: D000069450

- Term: Liraglutide

- ID: D000049528

- Term: Insulin, Long-Acting

- ID: C000629636

- Term: Xultophy

### Misc Info Module

- Version Holder: 2024-05-24
