Status:
COMPLETED
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.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04838743
Start Date
April 23 2021
End Date
October 26 2022
Last Update
December 31 2025
Active Locations (42)
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1
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Japan, Japan, 963 8851
2
Naka Kinen Clinic_Internal medicine
Naka, Ibaraki, Japan, Japan, 311 0113
3
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, Japan, 242-0004
4
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan, 862-0976