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Diabetes Mellitus, Type 2GOALNCT04838743

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.

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 42 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
IDegLira
How many people
244 participants
Where
42 sitesJapan
Study dates
23 Apr 2021to 26 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

Japan42 sites

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012

  • Yoshida Hospital

    Asahikawa-shi, Hokkaido, 070-0054

  • Nippon Medical School Hospital, Diabetes,Metabology,Endocrin

    Bunkyo-ku, Tokyo, 113-8603

  • Gengendo Kimitsu Hospital_Diabetes and Endocrinology

    Chiba, 299-1144

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

    Chuo-ku, Tokyo, 103-0002

  • Soyokaze CardioVascular Medicine and Diabetes Care

    Ehime, 790-0026

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006

  • Kawada Clinic

    Gunma, 373-0036

  • H.E.C Science Clinic

    Kanagawa, 235-0045

  • Chigasaki Municipal Hospital_Endocrinology and Metabolism

    Kanagawa, 253-0042

  • Asano Clinic

    Kawagoe-shi, Saitama, Japan, 350-0851

  • Hotaruno hakuyukai Medical Corporation of Japan

    Kisarazu-shi, Chiba, 292-0038

  • Gendai Clinic

    Kitakyusyu-shi, Fukuoka, 802-0974

  • Ohisama Clinic

    Kochi-shi, Kochi, 780-0082

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Japan, 963 8851

  • Jinnouchi Hospital_Internal Medicine

    Kumamoto, Kumamoto, Japan, 862-0976

  • Kawasaki Medical School Hospital_Diabetes, Endo and Metabo

    Kurashiki-shi, Okayama, 701-0192

  • The Jikei Medical University Hospital_Diabetes, Metabolism and Endo.

    Minatoku, 105-8471

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034

  • Nakayama Clinic_Nagoya-shi, Aichi

    Nagoya-shi, Aichi, 456-0058

  • Naka Kinen Clinic_Internal medicine

    Naka, Ibaraki, Japan, 311 0113

  • Abies Kanno Clinic

    Numakunai, 021-0002

  • Abe Diabetes Clinic_Internal Medicine

    Ōita, Oita, Japan, 870 0039

  • Okamoto Clinic for Diabetes and Endocrinology

    Ōita, 879-7301

  • Sumi Clinic

    Oita-shi, Oita, 870-0955

  • Oita Endocrinology Diabetes Clinic

    Oita-shi, Oita, 8700831

  • Takagi hospital, Internal Medicine

    Okawa-shi, Fukuoka, 831-0016

  • Kansai Electric Power Hospital_Center for Diabetes

    Osaka, 553-0003

  • Nakajima Diabetes Clinic

    Osaka, 553-0023

  • Matsuda Gastroenterology and Diabetes Clinic

    Osaka, 591-8006

  • Budounoki Clinic

    Saga-shi, Saga, 8400054

  • Japan Red Cross Shizuoka Hospital_Diabetes and Endocrinology

    Shizuoka, 420-0853

  • Suruga Clinic

    Shizuoka-shi, Shizuoka, 424-0853

  • Soka Sugiura Internal Medicine Clinic

    Soka-shi, Saitama, 340-0015

  • Higashi Diabetes and Cardiovascular Clinic, Internal

    Tamana-shi, Kumamoto, 865 0016

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022

  • Clinic Mirai Tachikawa

    Tokyo, 190-0023

  • Tamacenter Clinic Mirai

    Tokyo, 206-0033

  • Seishinkai Okamoto Naika Iin

    Yaizu-shi, Shizuoka, 425-0022

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004

Other trials in Japan

About this study

Official title: 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.

Being tested
IDegLira
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDegLiraDrug

    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.

Study groups in NCT04838743
Study groupRoleWhat they receive
IDegLiraReal-world adult population with type 2 diabetes mellitus in Japan.
Receives: Drug: IDegLira

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in local laboratory measured HbA1c (Glycated haemoglobin )

    % point

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

Secondary outcomes (5)

  1. Change in local laboratory measured FPG (Fasting plasma glucose )

    mg/dL

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

  2. 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

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

  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

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

  4. 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

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

  5. Change in daily dose of Xultophy®

    Dose

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start23 Apr 2021
  3. Primary completion26 Oct 2022
  4. Study completion26 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838743
Sponsor's protocol ID
NN9068-4743
Other IDs
U1111-1253-2025, jRCT1051210008
Acronym
GOAL
Status last verified
Dec 2025
First submitted
7 Apr 2021
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 42 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in local laboratory measured HbA1c (Glycated haemoglobin ) (time frame: From baseline (Visit 1) to 26 weeks (Visit 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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