Ambrisentan + Sotagliflozin for Type 1 Diabetes Kidney Protection

(ASPIRE Trial)

Recruiting at 6 trial locations

Overseen By Hiddo 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.

Research Team

Hiddo J Lambers Heerspink, PhD, PharmD

Principal Investigator

University Medical Center Groningen

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

You must have a body mass index of 21 or higher.

Your HbA1c level is between 6.5% and 10.5%.

I am willing and able to follow the study's required procedures.

Exclusion Criteria

I have been diagnosed with type 2 diabetes.

I have taken medication for high blood sugar in the last 3 months.

I often have low blood sugar without noticing.

Treatment Details

Interventions

• Ambrisentan (Endothelin Receptor Antagonist)
• Sotagliflozin (SGLT1/2 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment order 6 Experimental Treatment 3 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 5 Experimental Treatment 3 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 4 Experimental Treatment 3 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 3 Experimental Treatment 3 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 2 Experimental Treatment 3 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 1 Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University Medical Center Groningen

Lead Sponsor

Trials

770

Recruited

1,101,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Lexicon Pharmaceuticals

Industry Sponsor

Trials

67

Recruited

24,400+

Dr. Mike Exton

Lexicon Pharmaceuticals

Chief Executive Officer

PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany

Dr. Craig Granowitz

Lexicon Pharmaceuticals

Chief Medical Officer since 2021

MD