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

NCT ID: NCT05317845

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-21

Study Completion Date

2022-08-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Type 2 Diabetes (T2D)

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

No treatment given

Intervention Type 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.

Interventions

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No treatment given

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Manama, , Bahrain

Site Status

Novo Nordisk Investigational Site

Alexandria, , Egypt

Site Status

Novo Nordisk Investigational Site

Amman, , Jordan

Site Status

Novo Nordisk Investigational Site

As Sālimīyah, , Kuwait

Site Status

Novo Nordisk Investigational Site

Doha, , Qatar

Site Status

Novo Nordisk Investigational Site

Johannesburg, , South Africa

Site Status

Novo Nordisk Investigational Site

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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Bahrain Egypt Jordan Kuwait Qatar South Africa United Arab Emirates

References

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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.

Reference Type BACKGROUND
PMID: 36775980 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40994644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40754331 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40106223 (View on PubMed)

Other Identifiers

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U1111-1266-5511

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-007

Identifier Type: -

Identifier Source: org_study_id

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