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. (GOAL)

A Non-interventional, Single-arm, Multicentre, Prospective Study Investigating the Glycaemic Control and Treatment Pattern Associated With the Use of Xultophy® (IDegLira) in a Real-world Adult Population With Type 2 Diabetes Mellitus in Japan. GOAL (Glycaemic Outcome Assessment IDegLira) Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: IDegLira

• Study Type: Observational
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan, 468-0009
    • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  • Arakawa-ku, Tokyo, Japan, 116-0012
    • Kumanomae Nishimura Naika Clinic_Internal Medicine
  • Asahikawa-shi, Hokkaido, Japan, 070-0054
    • Yoshida Hospital
  • Bunkyo-ku, Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital, Diabetes,Metabology,Endocrin
  • Chiba, Japan, 299-1144
    • Gengendo Kimitsu Hospital_Diabetes and Endocrinology
  • Chiba-shi, Chiba, Japan, 260-0804
    • Akaicho Clinic
  • Chuo-ku, Tokyo, Japan, 103-0002
    • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
  • Ehime, Japan, 790-0026
    • Soyokaze CardioVascular Medicine and Diabetes Care
  • Fukuoka-shi, Fukuoka, Japan, 819-0006
    • Futata Tetsuhiro Clinic Meinohama_Internal medicine
  • Gunma, Japan, 373-0036
    • Kawada Clinic
  • Kanagawa, Japan, 235-0045
    • H.E.C Science Clinic
  • Kanagawa, Japan, 253-0042
    • Chigasaki Municipal Hospital_Endocrinology and Metabolism
  • Kisarazu-shi, Chiba, Japan, 292-0038
    • Hotaruno hakuyukai Medical Corporation of Japan
  • Kitakyusyu-shi, Fukuoka, Japan, 802-0974
    • Gendai Clinic
  • Kochi-shi, Kochi, Japan, 780-0082
    • Ohisama Clinic
  • Kurashiki-shi, Okayama, Japan, 701-0192
    • Kawasaki Medical School Hospital_Diabetes, Endo and Metabo
  • Minatoku, Japan, 105-8471
    • The Jikei Medical University Hospital_Diabetes, Metabolism and Endo.
  • Nagoya-shi, Aichi, Japan, 456-0058
    • Nakayama Clinic_Nagoya-shi, Aichi
  • Numakunai, Japan, 021-0002
    • Abies Kanno Clinic
  • Oita-shi, Oita, Japan, 8700831
    • Oita Endocrinology Diabetes Clinic
  • Oita-shi, Oita, Japan, 870-0955
    • Sumi Clinic
  • Okawa-shi, Fukuoka, Japan, 831-0016
    • Takagi hospital, Internal Medicine
  • Osaka, Japan, 591-8006
    • Matsuda Gastroenterology and Diabetes Clinic
  • Osaka, Japan, 553-0003
    • Kansai Electric Power Hospital_Center for Diabetes
  • Osaka, Japan, 553-0023
    • Nakajima Diabetes Clinic
  • Saga-shi, Saga, Japan, 8400054
    • Budounoki Clinic
  • Shizuoka, Japan, 420-0853
    • Japan Red Cross Shizuoka Hospital_Diabetes and Endocrinology
  • Shizuoka-shi, Shizuoka, Japan, 424-0853
    • Suruga Clinic
  • Soka-shi, Saitama, Japan, 340-0015
    • Soka Sugiura Internal Medicine Clinic
  • Tamana-shi, Kumamoto, Japan, 865 0016
    • Higashi Diabetes and Cardiovascular Clinic, Internal
  • Tochigi, Japan, 323-0022
    • Oyama East Clinic_Internal Medicine
  • Tokyo, Japan, 190-0023
    • Clinic Mirai Tachikawa
  • Tokyo, Japan, 206-0033
    • Tamacenter Clinic Mirai
  • Yaizu-shi, Shizuoka, Japan, 425-0022
    • Seishinkai Okamoto Naika Iin
  • Ōita, Japan, 879-7301
    • Okamoto Clinic for Diabetes and Endocrinology
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Japan, Japan, 963 8851
      • Seino Internal Medicine Clinic_Internal medicine
  • Ibaraki, Japan
    • Naka, Ibaraki, Japan, Japan, 311 0113
      • Naka Kinen Clinic_Internal medicine
  • Kanagawa
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
  • Kumamoto, Japan
    • Kumamoto, Kumamoto, Japan, Japan, 862-0976
      • Jinnouchi Hospital_Internal Medicine
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital_Internal Medicine
  • Oita, Japan
    • Ōita, Oita, Japan, Japan, 870 0039
      • Abe Diabetes Clinic_Internal Medicine
  • Saitama, Japan
    • Kawagoe-shi, Saitama, Japan, Japan, 350-0851
      • Asano Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 60 days prior to initiation of Xultophy® treatment. However, short term insulin treatment for a maximum of 14 days prior to initiation of Xultophy® treatment is allowed, as is prior insulin treatment for gestational diabetes.
• 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.

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

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

Drug: IDegLira; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in local laboratory measured HbA1c (Glycated haemoglobin )	% point	From baseline (Visit 1) to 26 weeks (Visit 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in local laboratory measured FPG (Fasting plasma glucose )	mg/dL	From baseline (Visit 1) to 26 weeks (Visit 3)
Number of patient-reported non-severe hypoglycaemic after initiation of treatment with Xultophy®	Count of episodes Non-severe hypoglycaemia: Defined as an episode with patient reported symptoms and/or self-measured plasma glucose value below 3.9 mmol/L (70 mg/dL). episodes	From baseline (Visit 1) to 26 weeks (Visit 3)
Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy®	Count of episodes Severe hypoglycaemia: Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action episodes	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)	Count of patients	From baseline (Visit 1) to 26 weeks (Visit 3)
Change in daily dose of Xultophy®	Dose	From baseline (Visit 1) to 26 weeks (Visit 3)

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): April 23, 2021
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; IDegLira
• Other Study ID Numbers: NN9068-4743; U1111-1253-2025 (Other Identifier: World Health Organization (WHO)); jRCT1051210008 (Registry Identifier: JAPIC (Japan))

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 device product: No