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Completed

NCT Number: NCT04838743

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.

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seino Internal Medicine Clinic_Internal medicine, Koriyama-shi, Fukushima, Japan, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    % point

Secondary outcomes

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

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    mg/dL

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

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    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

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

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    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

  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)

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    Count of patients

  5. Change in daily dose of Xultophy®

    Time frame: From baseline (Visit 1) to 26 weeks (Visit 3)

    Dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: GOAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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