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Endothelin Receptor Antagonist

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

Q: Am I eligible for enrollment in this scientific research?

Those hoping to be selected for this trial must have <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> and fit within the age bracket of 18-65. A total of 36 patients will eventually join the study.

Q: Are there any remaining vacancies on the project for participants?

Contrary to reports on clinicaltrials.gov, this experiment is not currently searching for potential subjects. It was originally posted on March 1st 2024 and the most recent update was made October 2nd 2023. Although participation in this trial has ended, there are still 1309 other trials actively recruiting participants.

Q: Are elderly participants accepted in this clinical study?

Per the inclusion criteria, this clinical trial is only accepting patients between 18 to 65 years old. For those younger or older than that range, there are 215 and 977 other trials respectively available for them to consider.

Q: Are multiple healthcare facilities providing access to this research in the city?

This trial is using medical centres such as Institute de Recherches Cliniques de Montreal in Montréal, Quebec, University of Toronto in Toronto, Uusimaa and Steno <a href="https://www.withpower.com/clinical-trials/diabetes">Diabetes</a> Center Copenhagen in Copenhagen Noord Holland to enrol participants. Other sites are also being used.

Q: Is Treatment order 1 a secure therapy option for people?

Due to the Phase 2 status of Treatment Order 1, Power determined that its safety rating should be a score of 2 on our scale. This reflects some existing data which suggests it is safe but not yet any evidence backing up its efficacy.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

ASPIRE Trial 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.Check my eligibility

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.See study design

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.

ASPIRE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is moderately reduced.

Select...

I am between 18 and 64 years old.

ASPIRE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change from baseline Extracellular Volume (ECV)

Change from baseline blood pressure

Change in biomarkers of fluid retention

+1 more

ASPIRE 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor

714 Previous Clinical Trials

979,110 Total Patients Enrolled

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,748 Total Patients Enrolled

Lexicon PharmaceuticalsIndustry Sponsor

63 Previous Clinical Trials

23,554 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible for enrollment in this scientific research?

"Those hoping to be selected for this trial must have type 1 diabetes and fit within the age bracket of 18-65. A total of 36 patients will eventually join the study."

Answered by AI

Are there any remaining vacancies on the project for participants?

"Contrary to reports on clinicaltrials.gov, this experiment is not currently searching for potential subjects. It was originally posted on March 1st 2024 and the most recent update was made October 2nd 2023. Although participation in this trial has ended, there are still 1309 other trials actively recruiting participants."

Answered by AI

Are elderly participants accepted in this clinical study?

"Per the inclusion criteria, this clinical trial is only accepting patients between 18 to 65 years old. For those younger or older than that range, there are 215 and 977 other trials respectively available for them to consider."

Answered by AI

Are multiple healthcare facilities providing access to this research in the city?

"This trial is using medical centres such as Institute de Recherches Cliniques de Montreal in Montréal, Quebec, University of Toronto in Toronto, Uusimaa and Steno Diabetes Center Copenhagen in Copenhagen Noord Holland to enrol participants. Other sites are also being used."

Answered by AI

Is Treatment order 1 a secure therapy option for people?

"Due to the Phase 2 status of Treatment Order 1, Power determined that its safety rating should be a score of 2 on our scale. This reflects some existing data which suggests it is safe but not yet any evidence backing up its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ambrisentan Sotagliflozin and Prevention of Renal Injury; a Randomized Evaluation

2024. "Ambrisentan Sotagliflozin and Prevention of Renal Injury; a Randomized Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072326.

All > Diabetic Kidney Disease