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.(NN9068-4743)

JRCT ID: jRCT1051210008

Registered date:21/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diebetes Mellitus
• Date of first enrollment: 23/04/2021
• Target sample size: 244
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in local laboratory measured HbA1c [Time Frame: From baseline (V1) to 26 weeks (V3)]

Secondary Outcome

Change in local laboratory measured FPG [Time Frame: From baseline (V1) to 26 weeks (V3)]
Number of patient-reported non-severe hypoglycaemicb episodes after initiation of treatment with Xultophy[Time Frame: From baseline (V1) to 26 weeks (V3)]
Number of patient-reported severe hypoglycaemicc episodes after initiation of treatment with Xultophy [Time Frame: From baseline (V1) to 26 weeks (V3)]
Change in concomitant OAD(s)a after initiation of treatment of Xultophy (Yes/No) [Time Frame: From baseline (V1) to 26 weeks (V3)]
Change in daily dose of Xultophy [Time Frame: From baseline (V1) to 26 weeks (V3)]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2.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.
3.Male or female, age above or equal to 20 years at the time of signing informed consent
4.Diagnosed with T2DM >=180 days prior to initiation of Xultophy treatment.
5.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.
6.Available and documented HbA1c value less or equal to 12 weeks prior to initiation of Xultophy treatment.

Exclude criteria

1.Previous participation in this study. Participation is defined as having given informed consent in this study.
2.Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of Xultophy.
3.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.
4.Previous treatment with Xultophy.
5.Female who is known pregnant, breast-feeding or intends to become pregnant.
6.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
7.Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Xultophy label in Japan.

Related Information

• Primary Sponsor: Sudoh Yuki
• Secondary ID(s): NCT04838743