SPRING - Assess the Clinical Care Pathway of Population With T2D and CKD in Four European Countries Using Real-world Data

NCT ID: NCT06769646

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

110074 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being carried out in 4 countries (France, Italy, Spain and the UK) to understand the clinical care pathway of population living with type 2 diabetes who also have evidence of chronic kidney disease.

The primary objective is to describe the population with T2D and CKD in terms of demography, clinical characteristics and medication use by CKD stage.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

People with T2D in THIN databases

Individuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD

No tretament given

Intervention Type OTHER

No treatment given

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No tretament given

No treatment given

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adults (18 years old or older) diagnosed with T2D and treated with an antidiabetic medication before or at index date, set up on 1 January 2021
2. With evidence of Kidney damage before or at index date:

1. diagnosed with CKD
2. or with a record of eGFR below 60 ml/min/1.73 m\^2
3. or with a record of uACR above 30 mg/g
3. Consulting a GP (all countries) or an Endocrinologist (France, Spain, Italy) or a Nephrologist (Spain) of the THIN® network.

Exclusion Criteria

1. aged less than 18 years old at index date
2. less than 360 days prior index date
3. less than 360 days after index date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational site

Bangalore, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1313-1011

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-8385

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.