Study design
Double blinded, randomised, placebo-controlled, crossover study. The treatment period is 2 x 12 weeks with 6 weeks washout.
Background and aim
Background: Sodium–glucose cotransporter inhibitors (SGLTi) were approved as adjunctive therapy for type 1 diabetes (T1D) in the EU between 2019-2021. The SGLTi have shown attractive effects in T1D by lowering of blood glucose without increased risk of hypoglycemia as well as a reduction in body weight and increased time in range. The major limitation for universal use of SGLTi in T1D is a substantial increase in the risk of diabetic ketoacidosis (DKA).
SGLTi have beneficial cardiovascular and renal effects in persons with type 2 diabetes (T2D) but there are no studies of whether these effects can also be demonstrated in people with T1D. In addition, the renal mechanisms of SGLT inhibition are incompletely understood, but effects on renal oxygenation and blood flow may play an important role.
Aim: - 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.
- Secondary endpoint are markers of nephropathy in persons with T1D.
- An additional aim is to evaluate if there are ethnic differences (African-Caribbean vs non-African-Caribbean) at baseline or in treatment responses.
Collaborators
Kings College Hospital, London.
Funding
JDRF is funding the study.
Project period
Start date: Spring 2024.
End date: Spring 2026.
Updated on 5 November 2023.