A Research Study Looking at Blood Sugar Control in People With Type 2 Diabetes Previously Treated With Premix Insulin and Initiating Treatment With Insulin Degludec/Liraglutide (IDegLira) in Local Clinical Practice in Croatia

Diabetes Mellitus, Type 2 Clinical Trial

— GLIDE  

Official title:

Glycaemic Control and Management in Adult Type 2 Diabetes Patients Previously Treated With Premix Insulins and Initiating Treatment With IDegLira in Routine Clinical Practice in Croatia: A 36-week Single Arm, Prospective, Multi-centre, Non-interventional Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05479591
• Other study ID #: NN9068-4972
• Secondary ID: U1111-1271-8967
• Status: Withdrawn
• Start date: July 30, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to look at the blood sugar control in participants with type 2 diabetes previously treated with premix insulins and initiating treatment with IDegLira. Participants will get IDegLira as prescribed by study doctor regardless of participant's decision to participate in the study. Decision to initiate treatment with IDegLira will be made by study doctor independent from the study. The study will last for about 36 weeks. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

• Male or female patients aged greater than or equal to (>=) 18 years at the time of signing informed consent.

• Patients diagnosed with T2D and receiving treatment with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines.

• Switched to treatment with IDegLira from previous treatment of premix insulins. The decision to initiate treatment with IDegLira must be independently from the decision to enrol in the study.

• Available and documented HbA1c collected within 12 weeks prior to initiation of IDegLira.

Exclusion Criteria:

• Previous participation in this study. Participation is defined as having given informed consent in this study.

• Participation in any other T2D clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to initiation of IDegLira.

• Previous treatment with IDegLira.

• Patients diagnosed with Type 1 diabetes mellitus.

• Female who is known to be pregnant, breastfeeding or intends to become pregnant during the conduct of the study.

• 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 IDegLira label in Croatia.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• IDegLira
Participants will be treated with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia and independent from the decision to include the participant in the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin A1c (HbA1c)	Measured in percentage (%) point.	From baseline to end of study (week 36 ± 6 weeks)
Secondary	Number of participants with HbA1c less than (<) 7.0%	Number of participants having Yes/No.	At end of study (week 36 ± 6 weeks)
Secondary	Starting dose of IDegLira	Measured in dose steps/day.	At baseline
Secondary	Dose of IDegLira at end of study	Measured in dose steps/day.	At end of study (week 36 ± 6 weeks)
Secondary	Change in body weight	Measured in kilograms (kg).	From baseline to end of study (week 36 ± 6 weeks)