Sotagliflozin
DrugSodium-glucose-co-transporter 1 and 2 inhibitor
Other names: Inpefa (TM)
NCT Number: NCT06147232
Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes also have increased risk of cardiovascular and kidney disease, and may benefit from SGLT-inhibition. The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown. Change in renal hypoxia may be a factor.
Objective: The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease.
Further aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent.
Additionally effects on left ventricular ejection fraction, kidney function and biomarkers in blood and urine will be explored.
Method: 12 weeks treatment with oral sotagliflozin or matching placebo as intervention. Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging. Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines.
Design: Randomized, double-blinded, placebo-controlled, cross over intervention study.
Study population: 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included, 39 at Steno Diabetes Center Copenhagen, 30 at King's College London.
Endpoints: Primary end-point: Change from 0 to 12 weeks in dynamic R2*-weighted signal after treatment with sotagliflozin compared to placebo. Secondary endpoints: Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion, renal artery flow, renal oxygen consumption, renal parenchymal triglyceride fraction, renal fibrosis, left ventricular ejection fraction, urinary albumin-creatinin ratio, ketone bodies, erythropoietin, pro brain natriuretic peptide, and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate.
Timeframe: Inclusion of patients from february 2024. Last visit september 2025. Presentation spring 2026, publication fall 2026.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Steno Diabetes Center Copenhagen, Herlev, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sodium-glucose-co-transporter 1 and 2 inhibitor
Other names: Inpefa (TM)
Placebo tablet
Time frame: 0 to 12 weeks in both treatment arms, last measure 30 weeks after randomization.
difference between change from 0 to 12 weeks after treatment with sotagliflozin compared to treatment with placebo
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Measured with MRI by arterial spin labelling in mL/g/min
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Renal artery flow measured by using phase contrast (PC) MRI. It is measured in mL/min.
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Renal oxygen consumption measured by MRI with T2-relaxation-under-spin-tagging.
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Renal parenchymal triglyceride fraction is measured by MRI spectroscopy
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Renal fibrosis is measured by MRI-derived apparent diffusion coefficient
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization
Left ventricular ejection fraction is assessed by MRI
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.
Urinary albumin-creatinine ratio (UACR) - morning void spot urine samples collected at home by participants.
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.
Capillary blood ketones, possibly measured by continous ketone monitoring device
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.
Measured from blood and urine samples using a commercially available panel from the company Olink. Includes 92 biomarkers.
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.
Analysis on blood samples at regional hospital laboratory.
Time frame: From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.
Analysis on blood samples at regional hospital laboratory.
Time frame: From 12 to 30 weeks after randomization
Glomerular filtration rate. At Steno Diabetes Center Copenhagen this will be measured by plasma clearance of Tc-99m diethylene-triamine-pentaacetate.
Time frame: From baseline to 30 weeks.
if African-Caribbean ethnicity is associated with any of the above secondary outcomes or baseline differences in cardio-renal disease markers/imaging measures
Contact information is provided by the study sponsor or research team.
Mette Brouw Iversen, MD
CONTACT
Peter Rossing, MD, DMSc
CONTACT
Steno Diabetes Center Copenhagen
Other
Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxia(PLUTO)
Acronym: PLUTO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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