ClinicalTrials.gg
RecruitingNCT07532863CRISTALSEAUpdated Jul 28, 2026

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

An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Recruiting at 6 sites in 4 countries. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Novo Nordisk A/S · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
40 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S — 21 open to participants now, 25 under way, 7 of them phase 3. Diabetes Mellitus, Type 2 · Novo Nordisk A/S.

Planned enrollment
150th of 215
400 · median 938
Started
2026
with 18 others
Observational
215 of 638
9 open now
Primary completion
2027-03
later than 4 of 24 live
Registered
626th of 638
by date

Among the 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, this one is the 150th largest by planned enrollment of the 215 observational ones that give a count, is one of 19 that started in 2026, is one of 215 observational ones, reaches primary completion later than 4 of the 24 other live ones, and was the 626th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

21 of the 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S are open now, in 12 countries. Recruiting first, the newest first:

15 more — sign in →

By country, each count listing its studies:

All 21 open studies →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 40 Years to 70 Years · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 638 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Diabetes Mellitus, Type 2
04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Participants with T2DM identified in south asian countries.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • T2DM Cohort

    Participants with T2DM identified in south asian countries.

    Other: No treatment given

Interventions

  • OtherNo treatment given

    No treatment given

06

What researchers measure

Primary outcomes

  1. Cardiometabolic profile: Systolic blood pressure at baseline

    Millimetres of mercury (mmHg).

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  2. Cardiometabolic profile: Waist circumference at baseline

    Measured in centimetre (cm).

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  3. Cardiometabolic profile: Hip circumference at baseline

    Measured in cm.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  4. Cardiometabolic profile: Height at baseline

    Measured in cm.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  5. Cardiometabolic profile: Weight at baseline

    Measured in kilogram (kg).

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  6. Cardiometabolic profile: Total cholesterol at baseline

    Measured in millimoles per liter (mmol/L).

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  7. Cardiometabolic profile: High-density lipoprotein cholesterol (HDL-C) at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  8. Cardiometabolic profile: Low-density lipoprotein cholesterol (LDL-C) at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  9. Cardiometabolic profile: Non High-density lipoprotein cholesterol (Non-HDL-C) at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  10. Cardiometabolic profile: Triglycerides at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  11. Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  12. Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline

    Measured in mmol/L.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  13. Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline

    Measured in mL/min/1.73m\^2.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  14. Cardiometabolic profile: Serum creatinine at baseline

    Measured in mL/min/1.73m\^2.

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

  15. Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No

    Measured in percentage (%) of participants.

    Time frame: At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date

07

Study locations

3 of 6 sites recruiting
  • Siloam Hospitals Lippo Village
    Tangerang, Banten 15810, Indonesia
    Not yet recruiting
  • Siloam Hospitals Surabaya
    Surabaya, East Java 60281, Indonesia
    Enrolling by invitation
  • University Malaya Medical Centre
    Lembah Pantai, Kuala Lumpur 59100, Malaysia
    Enrolling by invitation
  • National Heart Institute
    Kuala Lumpur, 50400, Malaysia
    Not yet recruiting
  • The Medical City Ortigas
    Pasig, National Capital Region 1800, Philippines
    Not yet recruiting
  • Novo Nordisk Investigational Site
    Singapore, Singapore
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2026
First posted
Apr 16, 2026
StartActual
Mar 13, 2026
Primary completionEst.
Mar 27, 2027
CompletionEst.
Mar 27, 2027
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07532863
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Mar 13, 2026
Primary completion
Mar 27, 2027 (estimated)
Completion
Mar 27, 2027 (estimated)
Last update
Jul 28, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency dept. 2834
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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