NCT07532863 A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants
| NCT ID | NCT07532863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novo Nordisk A/S |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-03-13 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Clinical Transparency dept. 2834
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07532863 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532863 currently recruiting?
Yes, NCT07532863 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07532863 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07532863 clinical trial?
NCT07532863 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency dept. 2834 at Novo Nordisk A/S. The trial plans to enroll 400 participants.
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