Overview

Combination GRA and SGLT-2i Treatment in Type 1 Diabetes

Status:
Active, not recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
JDRF
REMD Biotherapeutics, Inc.
The Leona M. and Harry B. Helmsley Charitable Trust
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
REMD-477
Volagidemab