drugset / Trial / NCT05696366
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Phase 1/2
Active not recruiting
24 enrolled
University of California, San Diego
Breakthrough T1D · collabLexicon Pharmaceuticals · collab
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2024-09-09
- Primary completion
- 2028-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sotagliflozin | Small molecule | 200 mg | Oral |
| Comparator | Volagidemab | Monoclonal antibody | 35 mg | Subcutaneous |