Diabetes Mellitus, Type 2PACT-MEANCT05317845
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
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 7 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 4,089 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 21 Apr 2022to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetes (T2D) patients seen in routine visits
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United Arab Emirates1 site
Novo Nordisk Investigational Site
Abu Dhabi
About this study
Official title: A Multi-center, Cross-sectional Chart Review and Survey to Capture the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa
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
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 Diabetes (T2D) | Selected for inclusion in the study by their primary or secondary care physicians Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope
Percentage patients
Measured: 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
Percentage patients
Measured: At the time of patient enrolment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start21 Apr 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317845
- Sponsor's protocol ID
- DAS-007
- Other IDs
- U1111-1266-5511
- Acronym
- PACT-MEA
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Publications
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.
PubMed 36775980Salek 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.
PubMed 40994644Assaad-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.
PubMed 40754331Haddad 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.
PubMed 40106223
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Cross-sectional Chart Review and Survey to Capture the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes Across Countries in the Middle East and Africa
- ClinicalTrials.gov ID
- NCT05317845
- Acronym / sponsor ID
- PACT-MEA / DAS-007
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,089 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes (T2D) | – | Other: No treatment givenSelected for inclusion in the study by their primary or secondary care physicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetes (T2D) patients seen in routine visits
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenThe 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. | Other | Patients with Type 2 Diabetes (T2D) |
Primary outcome
Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope
Time frame: At the time of patient enrolment (Day 1)
Percentage patients
1 secondary outcome
Proportion of T2D patients with high risk of Atherosclerotic cardiovascular disease (ASCVD) and without eASCVD
Time frame: At the time of patient enrolment (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 36775980Verma 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.
- Derived from this study: PubMed 40994644Salek 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.
- Derived from this study: PubMed 40754331Assaad-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.
- Derived from this study: PubMed 40106223Haddad 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.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bahrain, Egypt, Jordan, Kuwait, Qatar and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Established Atherosclerotic Cardiovascular Disease (eASCVD) pooled across all countries and separately for each country in scope (time frame: At the time of patient enrolment (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317845, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.