NCT07532863Recruiting
A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants
A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 6 Apr 2026
- Start date
- 13 Mar 2026
- Primary completion date
- 27 Mar 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT07532863
What you commit to
- Study type: Observational
- Planned participants: 400
- From 13 Mar 2026 to the primary completion date, 27 Mar 2027
- 6 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM
Other illness
- T1DM or gestational diabetes
- With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease
Other
- If any exclusion criterion is met, the participant will be excluded from the study.
- Pregnant women
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 70 years · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Siloam Hospitals Surabaya Coordinator of this site? Confirm its status | Surabaya | Indonesia | Enrolling by invitation |
| Siloam Hospitals Lippo Village Coordinator of this site? Confirm its status | Tangerang | Indonesia | Not yet recruiting |
| National Heart Institute Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Not yet recruiting |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Lembah Pantai | Malaysia | Enrolling by invitation |
| The Medical City Ortigas Coordinator of this site? Confirm its status | Pasig | Philippines | Not yet recruiting |
| Novo Nordisk Investigational Site Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.