drugset / Trial / NCT04545411
Combination GRA and SGLT-2i Treatment in Type 1 Diabetes
Phase 1/2
Completed
12 enrolled
University of California, San Diego
Juvenile Diabetes Research Foundation · collabREMD Biotherapeutics, Inc. · collabThe Leona M. and Harry B. Helmsley Charitable Trust · collab
RandomizedCrossoverTriple-blindBasic science
Summary
A pilot study for individuals with Type 1 Diabetes who are willing to add an SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor) in combination with placebo or a GRA (Glucagon Receptor Antagonist) to their current diabetes treatment regimen. There will be 15 study visits over approximately 14 weeks in this cross-over study design. Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and treatment "B" consists of an SGLT-2i + placebo for 4 weeks. All participants will complete both treatment "A" and treatment "B" with a 6-week washout period in between the treatments. Testing includes 3 insulin withdraw challenges, 3 muscle biopsies, 3 fat biopsies, 3 vascular ultrasounds along with blood collection and vitals.
Timeline
- Start
- 2021-02-22
- Primary completion
- 2022-02-28
- Completion
- 2022-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Volagidemab | Monoclonal antibody | 35 mg | Subcutaneous |
| Comparator | Dapagliflozin | Small molecule | 10 mg | Oral |