GOAL: A Research Study Looking at Long Term Blood Sugar Control in People With Type 2 Diabetes Treated With Xultophy® in Local Clinical Practice in Japan.

NCT04838743 | Completed

• 3 other identifiers: NN9068-4743U1111-1253-2025jRCT1051210008
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 42

Brief Summary

The purpose of this study is to collect information on how Xultophy® works with other oral anti diabetic medication in patients with type 2 diabetes. Participants will get Xultophy® as prescribed by the study doctor. The study will last for about 26 weeks. Participants will be asked questions about health and diabetes treatment and lab tests as part of normal doctor's appointment.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in local laboratory measured HbA1c (Glycated haemoglobin )

  % point

  From baseline (Visit 1) to 26 weeks (Visit 3)

Secondary Outcomes (5)

• Change in local laboratory measured FPG (Fasting plasma glucose )

  From baseline (Visit 1) to 26 weeks (Visit 3)

• Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®

  From baseline (Visit 1) to 26 weeks (Visit 3)

• Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®

  From baseline (Visit 1) to 26 weeks (Visit 3)

• Change in concomitant OAD(s) (Oral antidiabetic drugs ) including change in number, class, and frequency of concomitant OAD(s), after initiation of treatment of Xultophy® (Yes/No)

  From baseline (Visit 1) to 26 weeks (Visit 3)

• Change in daily dose of Xultophy®

  From baseline (Visit 1) to 26 weeks (Visit 3)

Study Arms (1)

IDegLira

Real-world adult population with type 2 diabetes mellitus in Japan.

Drug: IDegLira

Interventions

IDegLira DRUG

Patients will be treated with commercially available Xultophy® (IDegLira) in a pre-filled pen injector (FlexTouch®) at the discretion of the treating physician in accordance with the Xultophy® label in Japan. The decision to initiate treatment with Xultophy® is at the treating physician's discretion according to the approved Xultophy® label in Japan and independent from the decision to include the patient in the study.

IDegLira

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Real-world adult population with type 2 diabetes mellitus in Japan

You may qualify if:

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Male or female, age above or equal to 20 years at the time of signing informed consent
• Diagnosed with T2DM (Type 2 diabetes mellitus ) above or equal to 180 days prior to initiation of Xultophy® treatment.
• Treated with any oral anti-hyperglycaemic medication(s), except for oral GLP-1 RAs, for at least 60 days prior to initiation of Xultophy® treatment.
• Available and documented HbA1c value less or equal to 12 weeks prior to initiation of Xultophy® treatment.

You may not qualify if:

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before prior to initiation of Xultophy® (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening.).
• Previous treatment with Xultophy®.
• Female who is known pregnant, breast-feeding or intends to become pregnant.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Xultophy® label in Japan.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (42)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Japan, 963 8851, Japan

Location

Naka Kinen Clinic_Internal medicine

Naka, Ibaraki, Japan, 311 0113, Japan

Location

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, 862-0976, Japan

Location

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, 880-0034, Japan

Location

Abe Diabetes Clinic_Internal Medicine

Ōita, Oita, Japan, 870 0039, Japan

Location

Asano Clinic

Kawagoe-shi, Saitama, Japan, 350-0851, Japan

Location

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, 468-0009, Japan

Location

Kumanomae Nishimura Naika Clinic_Internal Medicine

Arakawa-ku, Tokyo, 116-0012, Japan

Location

Yoshida Hospital

Asahikawa-shi, Hokkaido, 070-0054, Japan

Location

Nippon Medical School Hospital, Diabetes,Metabology,Endocrin

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Gengendo Kimitsu Hospital_Diabetes and Endocrinology

Chiba, 299-1144, Japan

Location

Akaicho Clinic

Chiba-shi, Chiba, 260-0804, Japan

Location

The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

Chuo-ku, Tokyo, 103-0002, Japan

Location

Soyokaze CardioVascular Medicine and Diabetes Care

Ehime, 790-0026, Japan

Location

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Kawada Clinic

Gunma, 373-0036, Japan

Location

H.E.C Science Clinic

Kanagawa, 235-0045, Japan

Location

Chigasaki Municipal Hospital_Endocrinology and Metabolism

Kanagawa, 253-0042, Japan

Location

Hotaruno hakuyukai Medical Corporation of Japan

Kisarazu-shi, Chiba, 292-0038, Japan

Location

Gendai Clinic

Kitakyusyu-shi, Fukuoka, 802-0974, Japan

Location

Ohisama Clinic

Kochi-shi, Kochi, 780-0082, Japan

Location

Kawasaki Medical School Hospital_Diabetes, Endo and Metabo

Kurashiki-shi, Okayama, 701-0192, Japan

Location

The Jikei Medical University Hospital_Diabetes, Metabolism and Endo.

Minatoku, 105-8471, Japan

Location

Nakayama Clinic_Nagoya-shi, Aichi

Nagoya-shi, Aichi, 456-0058, Japan

Location

Abies Kanno Clinic

Numakunai, 021-0002, Japan

Location

Sumi Clinic

Oita-shi, Oita, 870-0955, Japan

Location

Oita Endocrinology Diabetes Clinic

Oita-shi, Oita, 8700831, Japan

Location

Takagi hospital, Internal Medicine

Okawa-shi, Fukuoka, 831-0016, Japan

Location

Kansai Electric Power Hospital_Center for Diabetes

Osaka, 553-0003, Japan

Location

Nakajima Diabetes Clinic

Osaka, 553-0023, Japan

Location

Matsuda Gastroenterology and Diabetes Clinic

Osaka, 591-8006, Japan

Location

Okamoto Clinic for Diabetes and Endocrinology

Ōita, 879-7301, Japan

Location

Budounoki Clinic

Saga-shi, Saga, 8400054, Japan

Location

Japan Red Cross Shizuoka Hospital_Diabetes and Endocrinology

Shizuoka, 420-0853, Japan

Location

Suruga Clinic

Shizuoka-shi, Shizuoka, 424-0853, Japan

Location

Soka Sugiura Internal Medicine Clinic

Soka-shi, Saitama, 340-0015, Japan

Location

Higashi Diabetes and Cardiovascular Clinic, Internal

Tamana-shi, Kumamoto, 865 0016, Japan

Location

Oyama East Clinic_Internal Medicine

Tochigi, 323-0022, Japan

Location

Clinic Mirai Tachikawa

Tokyo, 190-0023, Japan

Location

Tamacenter Clinic Mirai

Tokyo, 206-0033, Japan

Location

Seishinkai Okamoto Naika Iin

Yaizu-shi, Shizuoka, 425-0022, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: April 23, 2021
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (42)