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CompletedNCT05317845PACT-MEAUpdated Mar 28, 2023

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 in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4,089
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 4,089 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Type 2 Diabetes (T2D) patients seen in routine visits

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed 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

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as having given 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4,089 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with Type 2 Diabetes (T2D)

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

    Other: No treatment given

Interventions

  • OtherNo 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.

06

What researchers measure

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

    Time frame: 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

    Time frame: At the time of patient enrolment (Day 1)

07

Study locations

7 sites
  • Novo Nordisk Investigational Site
    Manama, Bahrain
  • Novo Nordisk Investigational Site
    Alexandria, Egypt
  • Novo Nordisk Investigational Site
    Amman, Jordan
  • Novo Nordisk Investigational Site
    Salmiya, Kuwait
  • Novo Nordisk Investigational Site
    Doha, Qatar
  • Novo Nordisk Investigational Site
    Johannesburg, South Africa
  • Novo Nordisk Investigational Site
    Abu Dhabi, United Arab Emirates
08

References and documents

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 36775980 ↗

Individual participant data

Plan to share: Yes — "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Data sharing details ↗ · novonordisk-trials.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05317845
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 8, 2022
Start date
Apr 21, 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Mar 28, 2023

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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