Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
University of California, San Diego
Summary
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.
Description
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. Up to 22 adult participants with type 1 diabetes (T1D) will be enrolled with at least 16 participants completing the study in full. After screening, baseline data (A1c, CGM, ambulatory insulin dosing, ambulatory ketones \[fasting and after infusion set change\], and psychosocial questionnaires) will be collected and participants will complete an insu…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 p…
Interventions
- DrugSotagliflozin
Sotagliflozin is a dual sodium-glucose co-transporter-1 and sodium-glucose co-transporter-2 (SGLT1/2) inhibitor.
- DrugVolagidemab
Volagidemab is a human monoclonal antibody glucagon receptor antagonist (GRA).
Location
- UC San Diego Altman Clinical & Translational Research InstituteLa Jolla, California