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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants with T2DM identified in south asian countries.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2DM Cohort; Participants with T2DM identified in south asian countries.	Other: No treatment given; No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiometabolic profile: Systolic blood pressure at baseline	Millimetres of mercury (mmHg).	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	Measured in centimetre (cm).	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	Measured in cm.	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	Measured in cm.	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	Measured in kilogram (kg).	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	Measured in millimoles per liter (mmol/L).	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	Measured in mmol/L.	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	Measured in mmol/L.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: Non High-density lipoprotein cholesterol (Non-HDL-C) at baseline	Measured in mmol/L.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: Triglycerides at baseline	Measured in mmol/L.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline	Measured in mmol/L.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline	Measured in mmol/L.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline	Measured in mL/min/1.73m^2.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Cardiometabolic profile: Serum creatinine at baseline	Measured in mL/min/1.73m^2.	At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No	Measured in percentage (%) of participants.	At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DAS-8606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No