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New drug combo aims to shield kidneys in type 1 diabetes

NCT ID NCT06072326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tests whether combining dapagliflozin (a diabetes drug) with SC0062 (a blood vessel drug) can better protect kidneys in adults with type 1 diabetes and chronic kidney disease. Thirty-six participants will try each treatment alone and together in a cross-over design. The main goal is to see if the combo reduces protein in urine, a sign of kidney damage.

What this could mean

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

Active substance
dapagliflozin (SGLT2 inhibitor) and SC0062 (endothelin receptor antagonist)
What this could lead to
If successful, this combination could offer a new way to protect kidneys in people with type 1 diabetes and slow kidney disease progression.
What could go wrong
This is a small, early-phase trial (36 people) testing short-term effects. The drugs may not work as hoped or could cause side effects like fluid retention or ketoacidosis.

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 36 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 65 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: * Willing and able to sign informed consent * Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent * WOCBP must have a negative pregnancy test at screening and must not be lactating. * Male individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, or be able to provide proof of vasectomy. * Female individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, provide proof of hysterectomy or sterilization, or be deemed menopausal based on a FSH-test. * Age ≥18 and \<65years, at the time of signing consent. * Body Mass Index ≥ 21 kg/m2 * Urinary albumin:creatinine ratio ≥ 50 mg/g and \<3000 mg/g * eGFR ≥30 and \<90 ml/min/1.73m2 * Stable RAAS inhibition medication for at least 4 weeks prior to screening * HbA1c ≥6.5 and \<10.5%. * Based on the Investigator's judgment participant must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed before randomization): * patient-led management and adjustment of insulin therapy * reliable approach to insulin dose adjustment for meals, such as carbohydrate counting * reliable and regular home-based blood glucose monitoring * established "sick day" management regimen Exclusion Criteria: * Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA). * Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months. * Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months. * Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months). * Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment. * Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 6 months. * Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g., immunocompromised patients, patients who might be at higher risk of developing urinary, genital or mycotic infections, patients with chronic viral infections, etc.). * Treatment with an SGLT2i within 30 days of Visit 1. * NT-proBNP \> 600 pg/mL * Hemoglobin \< 90 g/L * Diagnosis of severe edema (per investigator judgment) within 3 months of screening * Diagnosis of heart failure (NYHC stage III or IV).

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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

    7 sites in 3 countries. 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

  • Amsterdam University Academic Center

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Regionshospitalet Gødstrup

    Herning, 7400, Denmark

  • Steno Diabetes Center Aarhus

    Aarhus, 8200, Denmark

  • Steno Diabetes Center Copenhagen

    Copenhagen, 2730 Herlev, Denmark

  • Turku University Hospital

    Turku, 20520, Finland

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9700 RB, Netherlands

  • University of Helsinki

    Helsinki, Uusimaa, 00029 HUS, Finland