Cardiovascular risk profile in people newly diagnosed with type 2 diabetes in Southeast Asia

A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia

This project will see how cardiovascular risk is distributed among people aged 40–69 who were newly diagnosed with type 2 diabetes and started treatment in Southeast Asia using medical records from the year before and the first year after diagnosis.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (industry)
• Locations: 1 site (Singapore)
• Trial ID: NCT07532863 on ClinicalTrials.gov

What this trial studies

This is a retrospective chart-review using clinical records from participating centers across five Southeast Asian countries to characterize cardiovascular disease risk in people newly diagnosed with type 2 diabetes. Eligible participants are aged 40–69 and initiated anti-hyperglycemic therapy between January 1, 2022 and December 31, 2023. Researchers will use data from roughly the year before diagnosis and the first year after diagnosis to describe risk factors and the distribution of CVD risk, excluding people with prior atherosclerotic CVD or prior glucose-lowering therapy. No treatments are given as part of the project; data are analyzed to describe patterns and inform care planning in the region.

Who should consider this trial

Good fit: Ideal candidates are people aged 40–69 who were newly diagnosed with type 2 diabetes and started anti-hyperglycemic treatment between January 1, 2022 and December 31, 2023 at one of the participating Southeast Asian centers and who had at least one visit about 12 months after diagnosis.

Not a fit: People with type 1 or gestational diabetes, those who had anti-hyperglycemic drugs before their first recorded diagnosis, pregnant women, people with pre-existing atherosclerotic cardiovascular disease, or those who died or were lost to follow-up within 12 months after diagnosis will be excluded and are unlikely to benefit from inclusion.

Why it matters

Potential benefit: If successful, the findings could help clinicians and health systems in Southeast Asia identify common cardiovascular risk patterns in newly diagnosed type 2 diabetes and target earlier prevention.

How similar studies have performed: Retrospective and registry studies in other regions have described cardiovascular risk in people with type 2 diabetes, but large multi-country datasets focused on Southeast Asia remain limited.

Eligibility criteria

Inclusion Criteria:

* Aged greater than equal to (≥) 40 and less than (\<) 70 years
* Male or female
* Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023

Exclusion Criteria:

* If any exclusion criterion is met, the participant will be excluded from the study.
* T1DM or gestational diabetes
* Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM
* Pregnant women
* With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease
* Died within 12 months after first diagnosis of T2DM
* Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM

Where this trial is running

Singapore

• Novo Nordisk Investigational Site — Singapore, Singapore (RECRUITING)

Study contacts

• Study coordinator: Novo Nordisk

Conditions: Diabetes Mellitus, Type 2