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

Trial ID: NCT05696366

Interventional - Phase 1/2 - Active, not recruiting

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.

Conditions

• Type 1 Diabetes

Interventions

• Sotagliflozin
• Volagidemab

Eligibility

Inclusion criteria

• 1. Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening;
• 2. 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;
• 3. 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;
• 4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
• 5. 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;
• 6. Currently using a Continuous Glucose Monitoring (CGM) system;
• 7. A1c \> 7% and ≤ 10%
• 8. eGFR ≥ 60 mL/min/1.73m²;
• 9. Able to provide written informed consent approved by an Institutional Review Board (IRB).

Exclusion criteria

• 1. 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;
• 2. History of pancreatitis, medullary thyroid carcinoma or liver disease;
• 3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
• 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
• 5. Body Mass Index (BMI) \> 35 kg/m2
• 6. 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;
• 7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin);
• 8. Women who are pregnant or lactating/breastfeeding;
• 9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• 10. 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.

Sponsor

University of California, San Diego, Lexicon Pharmaceuticals, Breakthrough T1D

Source: ClinicalTrials.gov

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