Type 1 Diabetes Clinical Trial
Official title:
Effect of Glucagon Receptor Antagonism on Ketogenesis in SGLT-2i Treated Subjects With T1D
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.
This is a single-center, randomized, double-blind, cross-over, multi-dose study designed to elicit pilot data for a larger project. To accomplish the specific aims proposed, a single clinical trial will be conducted in which a maximum of 12 subjects with T1D, who are otherwise healthy, will be treated with an oral SGLT-2i (Sodium-Glucose Cotransporter-2 Inhibitor), 10mg dapagliflozin taken daily in combination with a GRA (Glucagon Receptor Antagonist), 70mg REMD-477 subcutaneous injection once a week or placebo (subcutaneous injection to match the volume of REMD-477) once a week. There will be two treatments: Treatment "A" consists of an SGLT-2i + GRA for 4 weeks and Treatment "B" consists of an SGLT-2i + placebo for 4 weeks. Participants will be randomly assigned to either start with Treatment A or Treatment B for the first 4 weeks of treatment. After completing the first treatment group, participants will be washed off all study drug for 6 weeks. After the washout period, participants will complete 4 weeks of dosing with the opposite treatment they received during the first 4 weeks. There will be 15 study visits as outlined below: 1. Screening - Complete medical history, physical exam, review current medications, height/weight, vital signs, ECG and fasting laboratory (blood and urine) tests. 2. Baseline 1 - Complete vitals, weight, physical exam, fasting blood collection, download CGM data, collect insulin usage, complete measurements of blood vessels using EndoPat and ultrasound, complete diabetes questionnaires, and complete fat and muscle biopsies. 3. Baseline 2 - Complete vitals, weight, fasting blood collection, insulin withdraw procedure and start first dose of study medications. 4. Visit 4 - Complete vitals, weight, dose 2 of REMD-477/Placebo, review CGM data and insulin dosing. 5. Visit 5 - Complete vitals, weight, dose 3 of REMD-477/Placebo, review CGM data and insulin dosing. 6. Visit 6 - Complete vitals, weight, dose 4 of REMD-477/Placebo, review CGM data and insulin dosing. 7. Repeat Measures 1 - Complete vitals, weight, physical exam, fasting blood collection, download CGM data, collect insulin usage, complete measurements of blood vessels using EndoPat and ultrasound, complete diabetes questionnaires, and complete fat and muscle biopsies. 8. Repeat Measures 2 - Complete vitals, weight, fasting blood collection, insulin withdraw procedure and begin wash-out of study medications. 9. Crossover Visit - Update medical history, complete physical exam, review of current medications, weight, vital signs, fasting laboratory (blood and urine) tests, collect insulin usage, download CGM data and start opposite doses of medication. 10. Visit 10 - Complete vitals, weight, dose 2 of REMD-477/Placebo, review CGM data and insulin dosing. 11. Visit 11 - Complete vitals, weight, dose 3 of REMD-477/Placebo, review CGM data and insulin dosing. 12. Visit 12 - Complete vitals, weight, dose 4 of REMD-477/Placebo, review CGM data and insulin dosing. 13. Final Measures 1 - Complete vitals, weight, physical exam, fasting blood collection, download CGM data, collect insulin usage, complete measurements of blood vessels using EndoPat and ultrasound, complete diabetes questionnaires, and complete fat and muscle biopsies. 14. Final Measures 2 - Complete vitals, weight, fasting blood collection, insulin withdraw procedure and review CGM data/insulin dosing for return to pre-baseline diabetes treatment. 15. Safety Follow-up - Complete vitals, physical exam, weight, and review CGM data/insulin dosing to verify diabetes treatment is stable. ;
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