dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

Prior treatment

• Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months.
• Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment.
• Treatment with an SGLT2i within 30 days of Visit 1.
• Strong CYP3A4 inducers or strong CYP3A4 inhibitors

Other illness

• Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA).
• 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.
• 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.).
• Diagnosis of heart failure (NYHC stage III or IV).

Lab values

• Hemoglobin \< 90 g/L

Other

• Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months).
• NT-proBNP \> 600 pg/mL
• Diagnosis of severe edema (per investigator judgment) within 3 months of screening

• 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