Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.
• Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening;
• Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
• Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
• Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
• Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closed loop system;
• Currently using a Continuous Glucose Monitoring (CGM) system;
• A1c \> 7% and ≤ 10%
• eGFR ≥ 60 mL/min/1.73m²;
• Able to provide written informed consent approved by an Institutional Review Board (IRB).