drugset / Trial / NCT04545411

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

NCT04545411

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

EvaluationDrugModalityDoseRoute
Comparator Volagidemab Monoclonal antibody 35 mg Subcutaneous
Comparator Dapagliflozin Small molecule 10 mg Oral