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ASPIRE-1: dApagliflozin SC0062 and Prevention of renal Injury; a Randomized Evaluation
EU CTIS ID: 2023-504404-28-00
What this study is testing
To examine the effects of dapagliflozin and SC0062 compared to SC0062 alone on albuminuria in adults with T1D and chronic kidney disease with elevated urinary albumin excretion.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to sign informed consent
- 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
- Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent
- Women of Childbearing Potential (WOCBP) must have a negative pregnancy test at screening and must not be lactating.
You likely can't join if
- Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA)
- 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
- Strong CYP3A4 inducers or strong CYP3A4 inhibitors
- Hemoglobin < 90 g/L
See the full eligibility criteria
Who can join
- Willing and able to sign informed consent
- 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
- Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent
- Women of Childbearing Potential (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
What rules you out
- Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA)
- 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
- Strong CYP3A4 inducers or strong CYP3A4 inhibitors
- 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.