RecruitingNCT07532863

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


Sponsor

Novo Nordisk A/S

Enrollment

400 participants

Start Date

Mar 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

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Interventions

OTHERNo treatment given

No treatment given


Locations(1)

Novo Nordisk Investigational Site

Singapore, Singapore

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NCT07532863


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