SC0062 and dapagliflozin: 20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Change from baseline in Urine Albumin-Creatinine Ratio (UACR) — 4 weeks Primary: change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.
Trial sites (7)
Facility
City
Region
Status
Steno Diabetes Center Aarhus
Aarhus
Denmark
Steno Diabetes Center Copenhagen
Copenhagen
Denmark
Regionshospitalet Gødstrup
Herning
Denmark
University of Helsinki
Helsinki
Uusimaa
Turku University Hospital
Turku
Finland
Amsterdam University Academic Center
Amsterdam
North Holland
University Medical Center Groningen
Groningen
Provincie Groningen
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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