Effects of GRA in Patients With Type 1

Effects of GRA in Patients With Type 1

This single-center, double-blind, placebo-controlled, multi-dose study is designed to evaluate the effects of glucagon antagonism on insulin sensitivity, cardiovascular risk and ketogenesis in individuals with Type 1 Diabetes. To accomplish the specific aims proposed, a single clinical trial will be conducted in which a maximum of 30 subjects with T1D, who are otherwise healthy, will be treated with REMD-477 or matching placebo for up to 12 weeks at a dose of 70mg (administered subcutaneously each week) with assessments done pre- and post-therapy. Subjects will be randomized on a 1:1 basis to either the REMD-477 group or placebo group and all subjects will remain on their standard of care insulin therapy throughout the study. There will be 19 study visits as outlined below:

Screening – Complete consenting process, complete medical history and physical exam, review of current medications, collect height/weight, vital signs, and fasting laboratory (blood and urine) tests.
Baseline Visit 1 – Participants that meet screening criteria will complete cardiovascular tests including flow mediated dilation and EndoPat, complete vital signs, weight and laboratory tests for safety and CVD markers.
Baseline Visit 2 – Participants will complete a 2-Step Hyperinsulinemic/Euglycemic clamp with tracer, Indirect Calorimetry, muscle and adipose tissue biopsies.
Baseline Visit 3 – Insulin withdrawal challenge and injection #1 of REMD-477 or placebo. Participants will suspend insulin delivery and remove insulin pump. Blood sugars and ketones will be monitored for up to 8 hours.
Visit 4 – Injection #2 of REMD-477 or placebo and blood collection for safety labs.
Visit 5 – Injection #3 of REMD-477 or placebo.
Visit 6 – Injection #4 of REMD-477 or placebo and blood collection for safety labs.
Visit 7 – Injection #5 of REMD-477 or placebo.
Visit 8 – Injection #6 of REMD-477 or placebo and blood collection for safety labs.
Visit 9 – Injection #7 of REMD-477 or placebo.
Visit 10 – Injection #8 of REMD-477 or placebo and blood collection for safety labs.
Visit 11 – Injection #9 of REMD-477 or placebo.
Visit 12 – Injection #10 of REMD-477 or placebo and blood collection for safety labs.
Visit 13 – Injection #11 of REMD-477 or placebo.
Visit 14 – Injection #12 of REMD-477 or placebo and blood collection for safety labs.
Visit 15 – Repeat cardiovascular tests including flow mediated dilation and EndoPat, complete vital signs, weight and laboratory tests for safety and CVD markers.
Visit 16 – Repeat 2-Step Hyperinsulinemic/Euglycemic clamp with tracer, Indirect Calorimetry, muscle and adipose tissue biopsies.
Visit 17 – Repeat Insulin withdrawal challenge. Participants will suspend insulin delivery and remove insulin pump. Blood sugars and ketones will be monitored for up to 8 hours.
Visit 18 – Safety follow-up visit that includes physical exam, vitals, blood and urine sample collection.

Source: View full study details on ClinicalTrials.gov

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November 11, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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