Type 2 Diabetes MellitusNCT07121114
CAPTIVATE India - A Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals With Type 2 Diabetes Mellitus (T2DM) in India
An observational study of Type 2 Diabetes Mellitus, run by Novo Nordisk A/S at 1 site in India.
Trial summary
This is a cross-sectional study assessing the prevalence of Cardiovascular Disease and describing cardio-renal risk factors among individuals with Type 2 Diabetes Mellitus in India based on medical records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- No treatment given
- How many people
- 1,500 participants
- Where
- 1 siteIndia
- Study dates
- 9 Apr 2025to 9 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM).
Who may be able to join
- Male or female individuals with type 2 diabetes mellitus (T2DM), aged above or equal to 18 years.
- A confirmed diagnosis of T2DM before ethical clearance at every participating institution.
- Medical records available between 01 January 2024 to 30 September 2024 ought to have the data points required for the primary and secondary objectives. Medical records must have at least 6 months (greater than or equal to 180 days) of follow-up data from the date of diagnosis.
Who cannot join
- Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY).
- Known congenital heart disease or malformation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAPTIVATE India - A Cross-Sectional Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals With Type 2 Diabetes Mellitus (T2DM) in India.
This is a cross-sectional study assessing the prevalence of Cardiovascular Disease and describing cardio-renal risk factors among individuals with Type 2 Diabetes Mellitus in India based on medical records.
- Conditions
- Type 2 Diabetes Mellitus
- 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 |
|---|---|---|
| Cohort 1 | The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM). Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with established Cardio Vascular Disease (CVD)
Proportion
Measured: From start of data collection to end of data collection (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start9 Apr 2025
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
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, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121114
- Sponsor's protocol ID
- DAS-8323
- Other IDs
- U1111-1310-3556
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 13 Aug 2025
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPTIVATE India - A Cross-Sectional Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals With Type 2 Diabetes Mellitus (T2DM) in India.
- ClinicalTrials.gov ID
- NCT07121114
- Acronym / sponsor ID
- DAS-8323
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 13 Aug 2025 (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.
This is a cross-sectional study assessing the prevalence of Cardiovascular Disease and describing cardio-renal risk factors among individuals with Type 2 Diabetes Mellitus in India based on medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No treatment givenThe population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM).
Key inclusion criteria (3 listed)
- Male or female individuals with type 2 diabetes mellitus (T2DM), aged above or equal to 18 years.
- A confirmed diagnosis of T2DM before ethical clearance at every participating institution.
- Medical records available between 01 January 2024 to 30 September 2024 ought to have the data points required for the primary and secondary objectives. Medical records must have at least 6 months (greater than or equal to 180 days) of follow-up data from the date of diagnosis.
Key exclusion criteria (2 listed)
- Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY).
- Known congenital heart disease or malformation.
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 | Cohort 1 |
Primary outcome
Proportion of individuals with established Cardio Vascular Disease (CVD)
Time frame: From start of data collection to end of data collection (approximately 3 months)
Proportion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- 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. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834), Study Director study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Novo Nordisk A/S at 1 site in India.
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 2 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals with established Cardio Vascular Disease (CVD) (time frame: From start of data collection to end of data collection (approximately 3 months)). 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 13 Aug 2025.