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New trial aims to match diabetes drugs to patients for better heart and kidney protection

NCT ID NCT07594145

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This phase 2 trial will test two drugs, finerenone and sotagliflozin, in 57 people with type 1 diabetes who are at risk for heart and kidney problems. The goal is to see if matching the right drug to each person's specific diabetes subtype can improve early signs of heart and kidney health. The study will measure changes in urine protein and a heart stress marker over 26 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
finerenone and sotagliflozin
What this could lead to
If successful, this trial could show that matching specific diabetes subtypes to targeted drugs helps protect the heart and kidneys in people with type 1 diabetes.
What could go wrong
This is a small, early-phase trial (57 people) testing short-term effects. The drugs may not work as hoped, and side effects are possible. Results may not apply to everyone with type 1 diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 57 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following: 1. presence of circulating T1D-associated autoantibodies, or 2. history of hospitalization for diabetic ketoacidosis, or 3. documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dL) 2. Aged 18-75 years, inclusive 3. T1D duration \>10 years 4. HbA1c: 7-10% 5. Meets one of the following, either 1. UACR \> 30 mg/dl with eGFR ≥ 60mL/min/1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or 2. Early (Stage B HF) defined as NT-proBNP ≥125 pg/mL 6. Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent Exclusion Criteria: 1. Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease 2. Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms 3. Current use of GLP-1 receptor agonists or other non-glucose lowering agent 4. Use of aldosterone inhibitors within 2 months prior to screening 5. Immunosuppressive medications within 3 months prior to screening 6. Systolic BP\>160 or diastolic BP \>95 mmHg at screening 7. History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening 8. Evidence of any episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening 9. Serum potassium \> 5.0 mmol/L at screening 10. Absolute neutrophil count \< 2.0 × 109 per L at screening 11. Platelet count \< 120 × 109 per L at screening 12. Known active tuberculosis, hepatitis B or C at screening, or history of HIV 13. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or AST or ALT \>2 times upper limit of normal, and/or total bilirubin \>1.3 times upper limit of normal at screening 14. History of severe acquired immune deficiency syndrome or severely immunocompromised status in the opinion of the study site investigator 15. History of biopsy-proven non-diabetic CKD 16. History of any other cause of HF (viral, congenital, valvular) 17. History of heart or renal transplant or currently on chronic dialysis 18. Cancer treatment, excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer, within one year prior to screening 19. Illicit drug abuse within 6 months prior to screening in the opinion of the study site investigator 20. Current heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) 21. Participation in another interventional clinical research study within 30 days prior to screening 22. Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial 23. Presence of a clinically significant medical history, physical examination, laboratory finding or other identified study site investigator concern that may interfere with any aspect of study conduct or interpretation of results

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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