Urinary proteomics to guide early intervention to prevent complications in type 2 diabetes – a feasibility study

2024-518682-95-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 20 Oct 2025 · Status Ongoing, recruiting · 2 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 70
Countries 2
Sites 2

Type 2 Diabetes

To explore the feasibility of using urinary proteomic signatures in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional reno-cardiovascular protective treatment. We will use urinary proteomic classifiers: CKD273, CAD160 and HF2 to identify …

Key facts

Sponsor
Steno Diabetes Center Copenhagen
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Not possible to specify
Trial duration
20 Oct 2025 → ongoing
Decision date (initial)
2025-02-09
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To explore the feasibility of using urinary proteomic signatures in clinical practice to identify patients at risk of developing end organ damage and identify which patients should receive additional reno-cardiovascular protective treatment. We will use urinary proteomic classifiers: CKD273, CAD160 and HF2 to identify patients suited for additional medical treatment with sodium-glucose-cotransporter-2-inhibitors, glucagon-like-peptide-1 receptor agonists or non-steroidal mineralocorticoid receptor antagonist.

Conditions and MedDRA coding

Type 2 Diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Type 2 diabetes with no clinical signs of heart failure, cardiovascular disease or diabetic kidney disease.

Exclusion criteria 1

  1. Manifest cardiovascular disease, heart failure (left ventricular ejection fraction <45%), micro- or macroalbuminuria with a urine albumin creatine ratio ≥ 200 mg/g or chronic kidney disease with an eGFR < 45 ml/min/1.73m2. Pregnancy or planed pregnancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Feasibility

Secondary endpoints 1

  1. Changes in urinary albumin excretion (≥30%), changes in urinary proteomic signatures and changes in eGFR levels (≥30%)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Dapagliflozin

SUB31650 · Substance

Active substance
Dapagliflozin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
1820 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dapagliflozin

SUB31650 · Substance

Active substance
Dapagliflozin
Pharmaceutical form
FILM COATED TABLETS
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
1820 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Finerenone

SUB183743 · Substance

Active substance
Finerenone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
3640 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Finerenone

SUB183743 · Substance

Active substance
Finerenone
Pharmaceutical form
COATED TABLET
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
3640 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
29 µg microgram(s)
Max total dose
52 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
29 µg microgram(s)
Max total dose
52 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
29 µg microgram(s)
Max total dose
52 mg milligram(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

13 Total trials 10 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Steno Diabetes Center Copenhagen
Address
Borgmester Ib Juuls Vej 83
City
Herlev
Postcode
2730
Country
Denmark

Scientific contact point

Organisation
Steno Diabetes Center Copenhagen
Contact name
Information desk

Public contact point

Organisation
Steno Diabetes Center Copenhagen
Contact name
Information desk

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

2 EU/EEA countries · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 50 1
Spain Ongoing, recruiting 20 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Steno Diabetes Center Copenhagen
Complications Research, Borgmester Ib Juuls Vej 83, 2730, Herlev

Spain

1 site · Ongoing, recruiting
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Nefrología, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-10-20 2025-12-08
Spain 2026-04-30 2026-05-13

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-518682-95 3.0
Recruitment arrangements (for publication) K1_Recruit arrangements 2024-518682-95 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_ES 1
Recruitment arrangements (for publication) K2_ Recruitment material for other website 2
Recruitment arrangements (for publication) K2_ Recruitment material for website steno 3.0
Recruitment arrangements (for publication) K2_ Recruitment material poster 2
Subject information and informed consent form (for publication) L1_Front page SIS 2.0
Subject information and informed consent form (for publication) L1_ICF 2024-518682-95_ES 1
Subject information and informed consent form (for publication) L1_Informed consent form 2.0
Subject information and informed consent form (for publication) L1_Informed consent form Biobank 2.0
Subject information and informed consent form (for publication) L1_SIS 2024-518682-95 3.1
Subject information and informed consent form (for publication) L2_Other subject information material Forsgspersoners rettigheder 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Forxiga 2024-518682-95 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Kerendia 2024-518682-95 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Ozempic 2024-518682-95 1
Synopsis of the protocol (for publication) D1_Protocol synopsis DK 2024-518682-95 1
Synopsis of the protocol (for publication) D1_Protocol synopsis ES 2024-518682-95 1

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-21 Denmark Acceptable
2025-01-29
 2025-02-09
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-02-10 Denmark Acceptable
2025-01-29
 2025-02-10
3 NON SUBSTANTIAL MODIFICATION NSM-2 2025-07-14 Denmark Acceptable
2025-01-29
 2025-07-14
4 NON SUBSTANTIAL MODIFICATION NSM-3 2025-07-14 Denmark Acceptable
2025-01-29
 2025-07-14
5 SUBSEQUENT ADDITION OF MSC APP-5 2025-07-16 2025-09-03
6 NON SUBSTANTIAL MODIFICATION NSM-4 2026-01-26 Denmark 2026-01-26
7 NON SUBSTANTIAL MODIFICATION NSM-5 2026-02-20 Denmark 2026-02-20

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