Prevention of CKD progression in type 1 diabetes with long term use of SGLTi avoiding kidney hypoxia
Research type
Research Study
Full title
Prevention of CKD progression in type 1 diabetes with Long term Use of SGLTi avoiding kidney hypOxia (PLUTO)
IRAS ID
1011652
Contact name
Mette Brouw Iversen
Contact email
Sponsor organisation
Steno Diabetes Center Copenhagen
Eudract number
2023-509450-55
Clinicaltrials.gov Identifier
Research summary
People with type 1 diabetes (T1D) are at high risk of kidney disease, with an annual incidence of albuminuria at 2-3%. Diabetic kidney disease develops in about 1/3 of patients with T1D, and excess mortality associated with T1D is mainly in patients with chronic kidney disease. Sotagliflozin lowers blood sugar in people with T1D and can help reduce body weight. In studies including those in people with type 2 diabetes, medications that block sodium-glucose cotransporters have shown benefits to the kidneys, heart, and blood vessels. These effects have not been studied sufficiently in people with T1D to date.
The PLUTO trial is a double-blinded, randomised, placebo-controlled, crossover trial of sotagliflozin. The aim is to evaluate if sotagliflozin changes the oxygen available in the kidneys for patients with T1D and albuminuria, assessed by magnetic resonance imaging (MRI) scans. An additional aim is to evaluate if there are ethnic differences at baseline or in treatment responses.
69 patients with T1D and albuminuria will be recruited, 39 at Steno Diabetes Center Copenhagen, Denmark and 30 at Guy’s and St Thomas’ NHS Foundation Trust, London, UK. The research will be funded by Breakthrough T1D.
Participants that consent to take part in the study will undergo a number of procedures across 9 visits (1 screening visit, 4 face-to-face visits and 4 visits where participants undergo an MRI scan). The participants will also be contacted via telephone four times throughout the trial. Visit procedures include; review of medical history/concomitant medication, blood draw, urine collection/analysis, MRI-scans of the heart/kidneys, vital signs, pulse oximetry, Glomerular Filtration Rate measurement, quality of life questionnaire, physical examination, ketone bodies, and 24-hour ambulatory blood pressure. Participants will be enrolled for 36 weeks, including: Two 12-week treatment periods (sotagliflozin 200mg daily and placebo), separated by a 6-week wash-out period.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0395
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion