Recruiting

A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants

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.

ClinicalTrials.gov IDNCT07532863

PhaseNot Applicable

Enrollment400

SponsorNovo Nordisk A/S

Age40 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Type 2

About this study

Interventions

Other: No treatment given — No treatment given

Primary outcomes

Cardiometabolic profile: Systolic blood pressure at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Waist circumference at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Hip circumference at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Height at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Weight at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Total cholesterol at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: High-density lipoprotein cholesterol (HDL-C) at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)
Cardiometabolic profile: Low-density lipoprotein cholesterol (LDL-C) at baseline (At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date)

Eligibility information

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

Study locations

Siloam Hospitals Lippo Village, Tangerang, Banten 15810 Indonesia
Siloam Hospitals Surabaya, Surabaya, East Java 60281 Indonesia
University Malaya Medical Centre, Lembah Pantai, Kuala Lumpur 59100 Malaysia
National Heart Institute, Kuala Lumpur, 50400 Malaysia
The Medical City Ortigas, Pasig, National Capital Region 1800 Philippines
Novo Nordisk Investigational Site, Singapore, Singapore

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.