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

July 27, 2026 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Indonesia
    • Banten
      • Tangerang, Banten, Indonesia, 15810
        • Not yet recruiting
        • Siloam Hospitals Lippo Village
    • East Java
      • Surabaya, East Java, Indonesia, 60281
        • Enrolling by invitation
        • Siloam Hospitals Surabaya
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Not yet recruiting
        • National Heart Institute
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Enrolling by invitation
        • University Malaya Medical Centre
  • Philippines
    • National Capital Region
      • Pasig, National Capital Region, Philippines, 1800
        • Not yet recruiting
        • The Medical City Ortigas
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiometabolic profile: Systolic blood pressure at baseline
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date
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
Time Frame: At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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