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 (PACT-MEA)

March 24, 2023 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4089

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 Diabetes (T2D) patients seen in routine visits

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Type 2 Diabetes (T2D)
Selected for inclusion in the study by their primary or secondary care physicians
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of patient enrolment (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Percentage patients
At the time of patient enrolment (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-007
  • U1111-1266-5511 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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