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New drug combo aims to shield kidneys in type 1 diabetes
NCT ID NCT06072326
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
7 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Amsterdam University Academic Center
Amsterdam, North Holland, 1081 HV, Netherlands
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Regionshospitalet Gødstrup
Herning, 7400, Denmark
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Steno Diabetes Center Aarhus
Aarhus, 8200, Denmark
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Steno Diabetes Center Copenhagen
Copenhagen, 2730 Herlev, Denmark
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Turku University Hospital
Turku, 20520, Finland
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University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB, Netherlands
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University of Helsinki
Helsinki, Uusimaa, 00029 HUS, Finland