Ambrisentan + Sotagliflozin for Type 1 Diabetes Kidney Protection (ASPIRE Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen ByHiddo J Lambers Heerspink, PhD, PharmD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Medical Center Groningen

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-65 with Type 1 Diabetes and diabetic kidney disease, who are not pregnant or lactating, can use effective contraception, have a stable medication regimen, and understand their condition. They must have specific levels of albumin in urine and kidney function. Those with recent severe hypoglycemia, heart issues, edema or other conditions that could affect safety/outcomes cannot join.

Inclusion Criteria

My kidney function is moderately reduced.

I am between 18 and 64 years old.

Exclusion Criteria

I have been diagnosed with type 2 diabetes.

I often have low blood sugar without noticing.

I have taken an SGLT2 inhibitor medication within the last 30 days.

I have been diagnosed with severe swelling or heart failure.

Participant Groups

The study tests if combining Sotagliflozin (a drug reducing sugar absorption) with Ambrisentan (which widens blood vessels) provides better protection against kidney damage in Type 1 Diabetics without causing fluid retention or increased ketone production compared to each drug alone.

6Treatment groups

Experimental Treatment

Group I: Treatment order 6Experimental Treatment3 Interventions

Subjects will start with 4 weeks of a combination of Ambrisentan and Sotagliflozin in period 1. In period 2 subjects will receive Sotagliflozin. In period 3 subjects will receive Ambrisentan. Between treatment periods there is a 4-week wash-out.

Group II: Treatment order 5Experimental Treatment3 Interventions

Subjects will start with 4 weeks of a combination of Ambrisentan and Sotagliflozin in period 1. In period 2 subjects will receive Ambrisentan. In period 3 subjects will receive Sotagliflozin. Between treatment periods there is a 4-week wash-out.

Group III: Treatment order 4Experimental Treatment3 Interventions

Subjects will start with 4 weeks of Sotagliflozine in treatment period 1. In period 2 subjects will receive Ambrisentan. In period 3 subjects will receive a combination of Ambrisentan and Sotagliflozin. Between treatment periods there is a 4-week wash-out.

Group IV: Treatment order 3Experimental Treatment3 Interventions

Subjects will start with 4 weeks of Sotagliflozine in treatment period 1. In period 2 subjects will receive a combination of Ambrisentan and Sotagliflozine. In period 3 subjects will receive Ambrisentan. Between treatment periods there is a 4-week wash-out.

Group V: Treatment order 2Experimental Treatment3 Interventions

Subjects will start with 4 weeks of Ambrisentan in treatment period 1. In period 2 subjects will receive a combination of Ambrisentan and Sotagliflozin. In period 3 subjects will receive Sotagliflozin. Between treatment periods there is a 4-week wash-out.

Group VI: Treatment order 1Experimental Treatment3 Interventions

Subjects will start with 4 weeks of Ambrisentan in treatment period 1. In period 2 subjects will receive Sotagliflozin. In period 3 subjects will receive a combination of Ambrisentan and Sotagliflozin. Between treatment periods there is a 4-week wash-out.