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Endothelin Receptor Antagonist

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

Phase 2

Waitlist Available

Led By Hiddo J Lambers Heerspink, PhD, PharmD

Research Sponsored by University Medical Center Groningen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

eGFR > 30 and <90 ml/min/1.73m2

Age ≥18 and <65 years, at the time of signing consent

Must not have

Diagnosis of type 2 diabetes

Hypoglycaemia unawareness or frequent unexplained hypoglycaemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a combination of two medicines can help protect kidneys, reduce fluid retention and stop ketogenesis in people with Type 1 Diabetes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include fluid retention leading to swelling or heart problems due to Ambrisentan; while Sotagliflozin might cause low blood sugar levels, dehydration from increased urination, genital infections due to sugar in the urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately reduced.

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with type 2 diabetes.

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I often have low blood sugar without noticing.

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

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I have been diagnosed with severe swelling or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change from baseline in Urine Albumin-Creatinine Ratio (UACR)

Secondary study objectives

Change from baseline Extracellular Volume (ECV)

Change from baseline blood pressure

Change in biomarkers of fluid retention

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ambrisentan

2020

Completed Phase 4

~2160

Sotagliflozin

2013

Completed Phase 3

~5700