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Clinical Trial Summary

The aim of this study is to test the hypothesis that sotagliflozin (SGLT1/2 inhibitor) and ambrisentan (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.


Clinical Trial Description

A phase 2, multicenter, randomized, open-label, cross-over trial will be conducted in male or female individuals (N=36) diagnosed with type 1 diabetes at least 6 months prior to informed consent aged between 18 and 65 years, Body Mass Index (BMI) ≥ 21 kg/m2, urinary albumin:creatinine ratio ≥ 50 mg/g and < 3000 mg/g, eGFR > 30 and <90 ml/min/1.73m2 and HbA1c between 6.5 and 10.0%. Patients have to be on stable RAAS inhibition for at least 4 weeks prior to screening. The study will consist of a screening visit, a 4-week run-in phase. After the run-in phase, the participant will be randomized to treatment of ambrisentan, sotagliflozin or their combination in random order. The duration of each treatment period is 4 weeks with study visits scheduled at 2 and 4 weeks in each treatment period. At the end of each treatment period patients proceed to a 4 weeks wash-out phase to study off drug effects. The total duration of the study for each participant after randomization is thus 24 weeks Interventions Ambrisentan 2.5 mg once daily; sotagliflozin 200mg once daily; combination of ambrisentan 2.5mg once daily and sotagliflozin 200mg once daily ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06072326
Study type Interventional
Source University Medical Center Groningen
Contact Hiddo J Lambers Heerspink, Phd, PharmD
Phone +31-50-3617859
Email h.j.lambers.heerspink@umcg.nl
Status Not yet recruiting
Phase Phase 2
Start date March 2024
Completion date March 2025

See also
  Status Clinical Trial Phase
Completed NCT02164279 - Validation of Biomarkers of Diabetic Nephropathy in Type I Diabetic Children
Completed NCT01521910 - Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy N/A