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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
