An International Chart Review and Survey for the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT05317845
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The study is intended to estimate the proportion and clinical management of people with type 2 diabetes having atherosclerotic cardiovascular diseases or who are at high risk to develop atherosclerotic cardiovascular diseases.

Participants will be asked to give information about their health. Partipants will continue normal way of life and will not get any medication other than those prescribed to them by the doctor.

The study will last for about 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Study Start: 2022-04-21
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4089

Inclusion Criteria

1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age greater than or equal to 18 years at the time of signing informed consent.
3. Diagnosed with T2D grater than or equal to 180 days prior to the day of signing informed consent

Exclusion Criteria

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation
3. Diagnosed with Type 1 Diabetes (T1D).
4. Patients with known congenital heart disease/malformation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes (T2D)	No treatment given	Selected for inclusion in the study by their primary or secondary care physicians

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope	At the time of patient enrolment (Day 1)	Percentage patients

Secondary Outcome Measures

Name	Time	Method
Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD	At the time of patient enrolment (Day 1)	Percentage patients

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇪 Abu Dhabi, United Arab Emirates