Status:
NOT_YET_RECRUITING
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Biocity Biopharmaceutics Co., Ltd.
Conditions:
Type 1 Diabetes Mellitus With Diabetic Nephropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 peo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06072326
Start Date
January 1 2026
End Date
December 1 2028
Last Update
October 7 2025
Active Locations (7)
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1
Steno Diabetes Center Aarhus
Aarhus, Denmark, 8200
2
Steno Diabetes Center Copenhagen
Copenhagen, Denmark, 2730 Herlev
3
Regionshospitalet Gødstrup
Herning, Denmark, 7400
4
University of Helsinki
Helsinki, Uusimaa, Finland, 00029 HUS