CAPTIVATE India - A Study to Assess the Prevalence of Car... | NCT07121114

Studies
CAPTIVATE India - A Study to Assess the Prevalence of Cardiovascular Disease (CVD) in Individuals With Type 2 Diabetes Mellitus (T2DM) in India

NCT07121114

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Aug 13, 2025Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

No treatment given

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1310-3556	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2025Actual

Primary Completion Date

Jul 9, 2025Actual

Completion Date

Jul 9, 2025Actual

First Submitted Date

Aug 7, 2025

First Submission Date that Met QC Criteria

Aug 7, 2025

First Posted Date

Aug 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM).	Other: No treatment given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No treatment given	Other	No treatment given	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of individuals with established Cardio Vascular Disease (CVD)	Proportion	From start of data collection to end of data collection (approximately 3 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Diagnosis of Type 1 diabetes, or maturity-onset diabetes of the young (MODY).
Known congenital heart disease or malformation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The population consists of male and female adults who have been diagnosed with type 2 diabetes mellitus (T2DM).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Transparency (dept. 2834), Study Director	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Bangalore	Karnataka	560045	India

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://novonordisk-trials.com

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided