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

NCT07121114 | Completed

• 2 other identifiers: DAS-8323U1111-1310-3556
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals with established Cardio Vascular Disease (CVD)

  Proportion

  From start of data collection to end of data collection (approximately 3 months)

Study Arms (1)

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

No treatment given OTHER

No treatment given

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bangalore, Karnataka, 560045, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834), Study Director

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 13, 2025
• Study Start: April 9, 2025
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)