Diabetes Mellitus, Type 2CRISTALSEANCT07532863
A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 400 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 13 Mar 2026to 27 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Adult, Older adult
Study population: Participants with T2DM identified in south asian countries.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Indonesia2 sites, 2 recruiting
- Enrolling by invitation
Siloam Hospitals Surabaya
Surabaya, East Java, 60281
- Not yet recruiting
Siloam Hospitals Lippo Village
Tangerang, Banten, 15810
Malaysia2 sites, 2 recruiting
- Not yet recruiting
National Heart Institute
Kuala Lumpur, 50400
- Enrolling by invitation
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Philippines1 site, 1 recruiting
- Not yet recruiting
The Medical City Ortigas
Pasig, National Capital Region, 1800
Singapore1 site, 1 recruiting
- Recruiting
Novo Nordisk Investigational Site
Singapore
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| T2DM Cohort | Participants with T2DM identified in south asian countries. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic profile: Systolic blood pressure at baseline
Millimetres of mercury (mmHg).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Mar 2026
- Primary completion27 Mar 2027 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532863
- Sponsor's protocol ID
- DAS-8606
- Acronym
- CRISTALSEA
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia
- ClinicalTrials.gov ID
- NCT07532863
- Acronym / sponsor ID
- CRISTALSEA / DAS-8606
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 27 Mar 2027 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM Cohort | – | Other: No treatment givenParticipants with T2DM identified in south asian countries. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with T2DM identified in south asian countries.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | T2DM Cohort |
Primary outcome
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).
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).
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Indonesia, Malaysia, Philippines, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.