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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)
• Intervention / Treatment: Other: No tretament given

• Study Type: Observational
• Enrollment (Actual): 110074

Contacts and Locations

Study Locations

• India
  • Bangalore, India
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with T2D in THIN databases; Individuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD	Other: No tretament given; No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of various CKD stages among patients with type 2 diabetes in the THIN database	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.	From the registration date to 1 January 2021

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: DAS-8385; U1111-1313-1011 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No