Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Más betegség

• History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
• History of pancreatitis, medullary thyroid carcinoma or liver disease;
• Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin);
• Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Laborértékek

• Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
• Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;

Egyéb

• Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
• Body Mass Index (BMI) \> 35 kg/m2
• Women who are pregnant or lactating/breastfeeding;
• Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;

• 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).