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Real-World study shows Xultophy's blood sugar control in japanese patients

NCT ID NCT04838743

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 244 adults with type 2 diabetes in Japan who were already prescribed Xultophy by their doctor. Researchers tracked blood sugar levels and low blood sugar episodes over 26 weeks to see how well the treatment works in everyday life. The goal was to understand real-world effectiveness, not to test a new drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

244 people

The number who actually took part.

Started

Apr 2021

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Abe Diabetes Clinic_Internal Medicine

    Ōita, Oita, Japan, 870 0039, Japan

  • Abies Kanno Clinic

    Numakunai, 021-0002, Japan

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804, Japan

  • Asano Clinic

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

  • Budounoki Clinic

    Saga-shi, Saga, 8400054, Japan

  • Chigasaki Municipal Hospital_Endocrinology and Metabolism

    Kanagawa, 253-0042, Japan

  • Clinic Mirai Tachikawa

    Tokyo, 190-0023, Japan

  • Futata Tetsuhiro Clinic Meinohama_Internal medicine

    Fukuoka-shi, Fukuoka, 819-0006, Japan

  • Gendai Clinic

    Kitakyusyu-shi, Fukuoka, 802-0974, Japan

  • Gengendo Kimitsu Hospital_Diabetes and Endocrinology

    Chiba, 299-1144, Japan

  • H.E.C Science Clinic

    Kanagawa, 235-0045, Japan

  • Heiwadai Hospital_Internal Medicine

    Miyazaki, Miyazaki, 880-0034, Japan

  • Higashi Diabetes and Cardiovascular Clinic, Internal

    Tamana-shi, Kumamoto, 865 0016, Japan

  • Hotaruno hakuyukai Medical Corporation of Japan

    Kisarazu-shi, Chiba, 292-0038, Japan

  • Japan Red Cross Shizuoka Hospital_Diabetes and Endocrinology

    Shizuoka, 420-0853, Japan

  • Jinnouchi Hospital_Internal Medicine

    Kumamoto, Kumamoto, Japan, 862-0976, Japan

  • Kansai Electric Power Hospital_Center for Diabetes

    Osaka, 553-0003, Japan

  • Kawada Clinic

    Gunma, 373-0036, Japan

  • Kawasaki Medical School Hospital_Diabetes, Endo and Metabo

    Kurashiki-shi, Okayama, 701-0192, Japan

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012, Japan

  • Matsuda Gastroenterology and Diabetes Clinic

    Osaka, 591-8006, Japan

  • Naka Kinen Clinic_Internal medicine

    Naka, Ibaraki, Japan, 311 0113, Japan

  • Nakajima Diabetes Clinic

    Osaka, 553-0023, Japan

  • Nakayama Clinic_Nagoya-shi, Aichi

    Nagoya-shi, Aichi, 456-0058, Japan

  • Nippon Medical School Hospital, Diabetes,Metabology,Endocrin

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Ohisama Clinic

    Kochi-shi, Kochi, 780-0082, Japan

  • Oita Endocrinology Diabetes Clinic

    Oita-shi, Oita, 8700831, Japan

  • Okamoto Clinic for Diabetes and Endocrinology

    Ōita, 879-7301, Japan

  • Oyama East Clinic_Internal Medicine

    Tochigi, 323-0022, Japan

  • Seino Internal Medicine Clinic_Internal medicine

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

  • Seishinkai Okamoto Naika Iin

    Yaizu-shi, Shizuoka, 425-0022, Japan

  • Soka Sugiura Internal Medicine Clinic

    Soka-shi, Saitama, 340-0015, Japan

  • Soyokaze CardioVascular Medicine and Diabetes Care

    Ehime, 790-0026, Japan

  • Sumi Clinic

    Oita-shi, Oita, 870-0955, Japan

  • Suruga Clinic

    Shizuoka-shi, Shizuoka, 424-0853, Japan

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009, Japan

  • Takagi hospital, Internal Medicine

    Okawa-shi, Fukuoka, 831-0016, Japan

  • Tamacenter Clinic Mirai

    Tokyo, 206-0033, Japan

  • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

    Chuo-ku, Tokyo, 103-0002, Japan

  • The Jikei Medical University Hospital_Diabetes, Metabolism and Endo.

    Minatoku, 105-8471, Japan

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004, Japan

  • Yoshida Hospital

    Asahikawa-shi, Hokkaido, 070-0054, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.