Clinical trial NCT05479591: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Type 2 Diabetes.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: From baseline to end of study (week 36 ± 6 weeks)
Secondary outcomes:
measure: Number of participants with HbA1c less than (<) 7.0%
timeFrame: At end of study (week 36 ± 6 weeks)
measure: Starting dose of IDegLira
timeFrame: At baseline
measure: Dose of IDegLira at end of study
timeFrame: At end of study (week 36 ± 6 weeks)
measure: Change in body weight
timeFrame: From baseline to end of study (week 36 ± 6 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: