Overview
Sponsor-declared trial summary
Type 1 Diabetes Mellitus with chronic kidney complications
The primary aim is to estimate the effect of three months treatment with sotagliflozin on renal oxygenation (MRI) in people with T1D and chronic kidney disease
Key facts
- Sponsor
- Steno Diabetes Center Copenhagen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Diseases [C] - Nutritional and Metabolic Diseases [C18], Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 1 Apr 2025 → ongoing
- Decision date (initial)
- 2024-08-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- JDRF · Lexicon Pharmaceuticals, Inc.
External identifiers
- EU CT number
- 2023-509450-55-01
- ClinicalTrials.gov
- NCT06147232
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy
The primary aim is to estimate the effect of three months treatment with sotagliflozin on renal oxygenation (MRI) in people with T1D and chronic kidney disease
Conditions and MedDRA coding
Type 1 Diabetes Mellitus with chronic kidney complications
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509450-55-00 | Prevention of CKD progression in type 1 diabetes with Long term Use of SGLTi avoiding kidney hypOxia (PLUTO) | Steno Diabetes Center Copenhagen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Adults with type 1 diabetes mellitus
- Chronic Kidney Disease and albuminuria
Exclusion criteria 4
- Non-diabetic Kidney Disease
- eGFR<25mL/min/1.73m^2, dialysis or kidney transplantation
- Previous diabetic ketoacidosis, except at debut
- Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerence of an SGLT inhibitor.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from 0 to 12 weeks in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation after treatment with sotagliflozin compared with placebo.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB179285 · Substance
- Active substance
- Sotagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 16800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo Product [Placebo Matching Sotagliflozin 200 MG Film-Coated Tablets]
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Steno Diabetes Center Copenhagen
- 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
- Mette Brouw Iversen
Public contact point
- Organisation
- Steno Diabetes Center Copenhagen
- Contact name
- Mette Brouw Iversen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 39 | 1 |
| Rest of world
United Kingdom
|
— | 30 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-04-01 | 2025-04-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_APPENDIX A 2023-509450-55 | 1 |
| Protocol (for publication) | D1_protocol_2023-509450-55 | 5 |
| Protocol (for publication) | D4 Ketone diary | 1 |
| Protocol (for publication) | D4 questionnaire EQ-5D-5L DA | 1 |
| Protocol (for publication) | D4 questionnarie EQ-5D-5L ENG | 1 |
| Protocol (for publication) | D4_Participation Card | 2 |
| Protocol (for publication) | D4_questionnarie | 1 |
| Recruitment arrangements (for publication) | K1_Front page | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4 |
| Recruitment arrangements (for publication) | K2_ Recruitment material for other websites | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material for website steno | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material poster | 1 |
| Subject information and informed consent form (for publication) | L1_ICF DA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS DA | 4 |
| Subject information and informed consent form (for publication) | L2 Dine rettigheder | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_DK 2023-509450-55 | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Denmark | Acceptable 2024-08-08
|
2024-08-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-05 | Denmark | Acceptable 2025-10-09
|
2025-10-17 |