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.
Arms and Interventions
Real-world adult population with type 2 diabetes mellitus in Japan.
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 Outcome Measures
- Change in local laboratory measured HbA1c (Glycated haemoglobin ) [From baseline (Visit 1) to 26 weeks (Visit 3)]
Secondary Outcome Measures
- 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)]
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
- Number of patient-reported severe hypoglycaemic after initiation of treatment with Xultophy® [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
- 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)]
Count of patients
- Change in daily dose of Xultophy® [From baseline (Visit 1) to 26 weeks (Visit 3)]
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.
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.
Contacts and Locations
|1||Novo Nordisk Investigational Site||Aichi||Japan||468-0009|
|2||Novo Nordisk Investigational Site||Asahikawa-shi, Hokkaido||Japan||070-0054|
|3||Novo Nordisk Investigational Site||Bunkyo-ku, Tokyo||Japan||113-8603|
|4||Novo Nordisk Investigational Site||Chiba||Japan||299-1144|
|5||Novo Nordisk Investigational Site||Chuo-ku, Tokyo||Japan||103-0002|
|6||Novo Nordisk Investigational Site||Ehime||Japan||790-0026|
|7||Novo Nordisk Investigational Site||Fukuoka-shi, Fukuoka||Japan||819-0006|
|8||Novo Nordisk Investigational Site||Gunma||Japan||373-0036|
|9||Novo Nordisk Investigational Site||Kanagawa||Japan||235-0045|
|10||Novo Nordisk Investigational Site||Kanagawa||Japan||253-0042|
|11||Novo Nordisk Investigational Site||Kitakyusyu-shi, Fukuoka||Japan||802-0974|
|12||Novo Nordisk Investigational Site||Kochi-shi, Kochi||Japan||780-0082|
|13||Novo Nordisk Investigational Site||Kumamoto||Japan||862-0976|
|14||Novo Nordisk Investigational Site||Kurashiki-shi, Okayama||Japan||701-0192|
|15||Novo Nordisk Investigational Site||Minato-ku||Japan||105-8471|
|16||Novo Nordisk Investigational Site||Naka-shi||Japan||311 0113|
|17||Novo Nordisk Investigational Site||Oita-shi, Oita||Japan||870-0955|
|18||Novo Nordisk Investigational Site||Oita-shi, Oita||Japan||8700831|
|19||Novo Nordisk Investigational Site||Oita-shi||Japan||870 0039|
|20||Novo Nordisk Investigational Site||Oita||Japan||879-7301|
|21||Novo Nordisk Investigational Site||Okawa-shi, Fukuoka||Japan||831-0016|
|22||Novo Nordisk Investigational Site||Osaka-shi||Japan||553-0023|
|23||Novo Nordisk Investigational Site||Osaka||Japan||553-0003|
|24||Novo Nordisk Investigational Site||Osaka||Japan||591-8006|
|25||Novo Nordisk Investigational Site||Saga-shi, Saga||Japan||8400054|
|26||Novo Nordisk Investigational Site||Shizuoka-shi, Shizuoka||Japan||424-0853|
|27||Novo Nordisk Investigational Site||Shizuoka||Japan||420-0853|
|28||Novo Nordisk Investigational Site||Tamana-shi, Kumamoto||Japan||865 0016|
|29||Novo Nordisk Investigational Site||Tochigi||Japan||323-0022|
|30||Novo Nordisk Investigational Site||Tokyo||Japan||190-0023|
|31||Novo Nordisk Investigational Site||Tokyo||Japan||206-0033|
Sponsors and Collaborators
- Novo Nordisk A/S
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study Documents (Full-Text)None provided.