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

Completed

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

• Registration Number: NCT06769646
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-12-02
• Study First Submitted: 2024-12-09
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-06
• Study First Submitted QC: 2025-01-07
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110074

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of various CKD stages among patients with type 2 diabetes in the THIN database	From the registration date to 1 January 2021	* Distribution of CKD stages, as determined by eGFR, in patients with and w/out CKD diagnosis; * (+/- ACD-10 code for CKD) in cohort of patients diagnosed with T2D.

Trial Locations

Locations (1)

Novo Nordisk Investigational site; 🇮🇳 Bangalore, India