Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)NCT06769646
SPRING - Assess the Clinical Care Pathway of Population With T2D and CKD in Four European Countries Using Real-world Data
An observational study of Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD), run by Novo Nordisk A/S at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)
- What is being tested?
- No tretament given
- How many people
- 110,074 participants
- Where
- 1 siteIndia
- Study dates
- 2 Dec 2024to 6 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD
Who may be able to join
- 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
- With evidence of Kidney damage before or at index date:
- diagnosed with CKD
- or with a record of eGFR below 60 ml/min/1.73 m^2
- or with a record of uACR above 30 mg/g
- Consulting a GP (all countries) or an Endocrinologist (France, Spain, Italy) or a Nephrologist (Spain) of the THIN® network.
Who cannot join
- aged less than 18 years old at index date
- less than 360 days prior index date
- less than 360 days after index date
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- No tretament given
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No tretament givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| People with T2D in THIN databases | Individuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD Receives: Other: No tretament given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the registration date to 1 January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Dec 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110,074 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769646
- Sponsor's protocol ID
- DAS-8385
- Other IDs
- U1111-1313-1011
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPRING - Assess the Clinical Care Pathway of Population With T2D and CKD in Four European Countries Using Real-world Data
- ClinicalTrials.gov ID
- NCT06769646
- Acronym / sponsor ID
- DAS-8385
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110,074 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with T2D in THIN databases | – | Other: No tretament givenIndividuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from the THIN® France, THIN® Italy, THIN® Spain and THIN® UK databases living with T2D and CKD
Key inclusion criteria (6 listed)
- 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
- With evidence of Kidney damage before or at index date:
- Consulting a GP (all countries) or an Endocrinologist (France, Spain, Italy) or a Nephrologist (Spain) of the THIN® network.
Key exclusion criteria (3 listed)
- aged less than 18 years old at index date
- less than 360 days prior index date
- less than 360 days after index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No tretament givenNo treatment given | Other | People with T2D in THIN databases |
Primary outcome
Prevalence of various CKD stages among patients with type 2 diabetes in the THIN database
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD), run by Novo Nordisk A/S at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of various CKD stages among patients with type 2 diabetes in the THIN database (time frame: From the registration date to 1 January 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.