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

NCT05317845 | Completed

• 2 other identifiers: DAS-007U1111-1266-5511
• Study Type: observational
• Target: 4,089
• Locations: 7 countries
• Sites: 7

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope

  Percentage patients

  At the time of patient enrolment (Day 1)

Secondary Outcomes (1)

• Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD

  At the time of patient enrolment (Day 1)

Study Arms (1)

Patients with Type 2 Diabetes (T2D)

Selected for inclusion in the study by their primary or secondary care physicians

Other: No treatment given

Interventions

No treatment given OTHER

The clinical management and prescribed treatment of diabetes and eASCVD/ASCVD risk factors are independent of this study and are part of the routine clinical practice at the discretion of the treating physician.

Patients 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

Type 2 Diabetes (T2D) patients seen in routine visits

You may qualify if:

• Signed informed 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, age greater than or equal to 18 years at the time of signing informed consent.
• Diagnosed with T2D grater than or equal to 180 days prior to the day of signing informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (7)

Novo Nordisk Investigational Site

Manama, Bahrain

Location

Novo Nordisk Investigational Site

Alexandria, Egypt

Location

Novo Nordisk Investigational Site

Amman, Jordan

Location

Novo Nordisk Investigational Site

As Sālimīyah, Kuwait

Location

Novo Nordisk Investigational Site

Doha, Qatar

Location

Novo Nordisk Investigational Site

Johannesburg, South Africa

Location

Novo Nordisk Investigational Site

Abu Dhabi, United Arab Emirates

Location

Related Publications (4)

• Verma S, Sabbour H, Alamuddin N, Alawadi F, Alkandari H, Almahmeed W, Assaad-Khalil SH, Haddad J, Lombard L, Malik RA, Mashaki Ceyhan E, Prasad P, Tombak G, Salek S. A cross-sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa (PACT-MEA): Study design and rationale. Diabetes Obes Metab. 2023 Jun;25(6):1444-1452. doi: 10.1111/dom.15011. Epub 2023 Mar 3.

  PMID: 36775980 BACKGROUND

• Salek S, Sabbour H, Alamuddin N, Alawadi F, Alkandari H, Almahmeed W, Assaad-Khalil SH, Ceyhan EM, Haddad J, Lombard L, Ngome M, Malik RA, Yadav G. Physician self-reported factors driving clinical decision-making in management of patients with T2D and ASCVD/high risk of ASCVD across the middle East and Africa: a cross-sectional study. Front Pharmacol. 2025 Sep 9;16:1558515. doi: 10.3389/fphar.2025.1558515. eCollection 2025.

  PMID: 40994644 DERIVED

• Assaad-Khalil SH, Bassyouni A, Toaima D, Gawish HS, El Hefnawy H, Megallaa M, Abushady M, ElKafrawy N, Hosny SS, Massoud TM. Prevalence and risk factors of atherosclerotic cardiovascular disease in Egyptians with type 2 diabetes: findings from the PACT-MEA study and call for action. BMJ Open. 2025 Aug 3;15(8):e092861. doi: 10.1136/bmjopen-2024-092861.

  PMID: 40754331 DERIVED

• Haddad JA, Annabi FOA, Abbasi H, AlSamen MAA, Ammari FL, Haddad FH, Haddad SE, Jaradat M, Khassawneh A, Khatib N, Magableh A, Al-Mousa E. The Prevalence of Atherosclerotic Cardiovascular Disease in Patients with Type 2 Diabetes in Jordan: The PACT-MEA Study. Diabetes Ther. 2025 May;16(5):899-913. doi: 10.1007/s13300-025-01718-7. Epub 2025 Mar 19.

  PMID: 40106223 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: April 21, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

KU (1); QA (1); ZA (1); AE (1); BA (1); EG (1); JO (1)