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

NCT05479591 | Withdrawn

• 2 other identifiers: NN9068-4972U1111-1271-8967
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin A1c (HbA1c)

  Measured in percentage (%) point.

  From baseline to end of study (week 36 ± 6 weeks)

Secondary Outcomes (4)

• Number of participants with HbA1c less than (<) 7.0%

  At end of study (week 36 ± 6 weeks)

• Starting dose of IDegLira

  At baseline

• Dose of IDegLira at end of study

  At end of study (week 36 ± 6 weeks)

• Change in body weight

  From baseline to end of study (week 36 ± 6 weeks)

Study Arms (1)

Participants with type 2 diabetes (T2D)

Participants with T2D previously treated with premix insulin for at least 12 weeks (3 months) based on local clinical guidelines will initiate treatment with IDegLira at the treating physician's discretion according to the approved IDegLira label in Croatia.

Drug: IDegLira

Interventions

IDegLira DRUG

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.

Also known as: Xultophy

Participants with type 2 diabetes (T2D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Type 2 Diabetes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira; Xultophy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: July 30, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share