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

NCT07532863 | Recruiting

• 1 other identifier: DAS-8606
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (1)

T2DM Cohort

Participants with T2DM identified in south asian countries.

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

T2DM Cohort

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with T2DM identified in south asian countries.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)