Type 1 Diabetes Mellitus With Diabetic NephropathyPhase 2ASPIRE-1NCT06072326
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
A Phase 2 study testing Dapagliflozin (Forxiga®), SC0062 strength 10mg and SC0062 and dapagliflozin in people with Type 1 Diabetes Mellitus With Diabetic Nephropathy, run by University Medical Center Groningen at 5 sites in 2 countries.
Trial summary
The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Diabetic Nephropathy
- What is being tested?
- Dapagliflozin (Forxiga®), SC0062 strength 10mg and SC0062 and dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2027to Jan 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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).
- Strong CYP3A4 inducers or strong CYP3A4 inhibitors
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Denmark3 sites
Steno Diabetes Center Aarhus
Aarhus, 8200
Søren T Knudsen
Steno Diabetes Center Copenhagen
Copenhagen, 2730 Herlev
Tine W Hansen
Regionshospitalet Gødstrup
Herning, 7400
Jesper N Bech
Finland2 sites
University of Helsinki
Helsinki, Uusimaa, 00029 HUS
Daniel Gordin
Turku University Hospital
Turku, 20520
Tapio A. Hellman
About this study
Official title: Individual and Combined Endothelin Receptor and SGLT2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial
The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.
Read the detailed description
A phase 2, multicenter, randomized, open-label, cross-over trial will be conducted in male or female individuals (N=36) diagnosed with type 1 diabetes at least 6 months prior to informed consent aged between 18 and 65 years, Body Mass Index (BMI) ≥ 21 kg/m2, urinary albumin: creatinine ratio ≥ 50 mg/g and < 3000 mg/g, eGFR > 30 and <90 mL/min/1.73 m2 and HbA1c > 6.5 and <10.5%. Patients have to be on stable RAAS inhibition for at least 4 weeks prior to screening.
The study will consist of a screening visit, a 4-week run-in phase. After the run-in phase, the participant will be randomized to treatment of SC0062, dapagliflozin, or their combination in random order. The duration of each treatment period is 4 weeks with study visits scheduled at 2 and 4 weeks in each treatment period. At the end of each treatment period patients proceed to a 4 weeks wash-out phase to study off drug effects. The total duration of the study for each participant after randomization is thus 24 weeks
Interventions SC0062 10mg twice daily (20mg/day); dapagliflozin 5mg once daily; combination of SC0062 10mg twice daily and dapagliflozin 5mg once daily.
- Being tested
- Dapagliflozin (Forxiga®), SC0062 strength 10mg, SC0062 and dapagliflozin
- Keywords
- Diabetic kidney disease, sodium glucose co-transporter 2 inhibitors, endothelin receptor antagonists, Type 1 Diabetes, combination therapy
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (Forxiga®)Drug
5 mg/day as a tablet
SC0062 strength 10mgDrug
20 mg/day, once daily, 2 capsules of 10 mg
SC0062 and dapagliflozinDrug
20 mg/day, once daily, 2 capsules of 10 mg, in combination with 5 mg/day dapagliflozin 5 mg as a tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment order 1 | Experimental | Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
| Treatment order 2 | Experimental | Subjects will start with 4 weeks of SC0062 in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
| Treatment order 3 | Experimental | Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive a combination of SC0062 and dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
| Treatment order 4 | Experimental | Subjects will start with 4 weeks of dapagliflozin in treatment period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive a combination of SC0062 and dapagliflozin. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
| Treatment order 5 | Experimental | Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive SC0062. In period 3 subjects will receive dapagliflozin. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
| Treatment order 6 | Experimental | Subjects will start with 4 weeks of a combination of SC0062 and dapagliflozin in period 1. In period 2 subjects will receive dapagliflozin. In period 3 subjects will receive SC0062. Between treatment periods there is a 4-week wash-out. Receives: Drug: Dapagliflozin (Forxiga®); Drug: SC0062 strength 10mg; Drug: SC0062 and dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Urine Albumin-Creatinine Ratio (UACR)
Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Secondary outcomes (7)
Change from baseline in eGFR
Estimated Glomerular Filtration Rate (GFR) - creatinine
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Change in biomarkers of fluid retention
Change from baseline biomarkers of fluid retention (Body Weight)
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Change in biomarkers of fluid retention
Change from baseline biomarkers of fluid retention (hemoglobin)
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Change in biomarkers of fluid retention
Change from baseline biomarkers of fluid retention (N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP))
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Change from baseline Extracellular Volume (ECV)
Extracellular volume (ECV) using iohexol clearance techniques and bioimpedance spectroscopy.
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Change from baseline blood pressure
Change in blood pressure as measure in mmHg
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Safety of dapagliflozin, SC0062, and combination of dapagliflozin and SC0062
Body weight, vital signs, physical examination findings, ECG, and clinical laboratory parameters AEs, Serious AEs, DKA, and drug-induced liver injury.
Measured: From randomization to end of study (V10) up to approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter, open-label randomized cross-over trial
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Biocity Biopharmaceutics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hiddo J Lambers Heerspink, PhD, PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072326
- Sponsor's protocol ID
- 17042
- Other IDs
- 2026-525684-40-01
- Acronym
- ASPIRE-1
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No