NCT03811288|Completed

An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes

CAPTURE-IO

A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN2211-4446U1111-1215-4005

Study Type

observational

Target

7,548

Locations

10 countries

Sites

164

Timeline

RegisteredJan 2019

StartedDec 2018

CompletionSep 2019

Brief Summary

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. Participants' participation will be one day/one visit at their doctor. The study will last for about 6 months in total.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

7,548

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach

10 countries

164 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

December 10, 2018

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed

Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

January 18, 2019

Last Update Submit

June 5, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Participants with a history of established cardiovascular disease (CVD)
Participants having a history of established CVD, i.e. who have been diagnosed with any one of the following listed conditions (yes/no): Cerebrovascular disease, cardiovascular disease, symptomatic heart failure, asymptomatic heart failure, hospitalisation for heart failure, cardiac arrhythmia, aortic disease, peripheral artery disease or carotid artery disease.
Day 1

Secondary Outcomes (1)

Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Day 1

Study Arms (1)

Participants with type 2 diabetes mellitus (T2DM)

T2DM patients being managed in both primary and specialist care in 10 selected countries.

Other: No treatment given

Interventions

No treatment givenOTHER

No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.

Participants with type 2 diabetes mellitus (T2DM)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will consist of male and female adults diagnosed with T2DM.

You may qualify if:

Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
Male or female, age more than or equal to 18 years at the time of signing informed consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20 years).
Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the informed consent

You may not qualify if:

Previous participation in this study. Participation is defined as having given informed consent in this study
Diagnosed with Type 1 diabetes
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Patients with known congenital heart disease/malformation

Contact the study team to confirm eligibility.