Status:
ACTIVE_NOT_RECRUITING
Effects of GRA in Patients With Type 1
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
REMD Biotherapeutics, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine the effects a Glucagon Receptor Antagonist (GRA), has on Insulin Sensitivity, Cardiovascular risks (CVD), and Ketone body formation in participants with Type 1 diabetes. The pa...
Detailed Description
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 individ...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening;
- Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
- Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
- Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria for \> 5 years;
- Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump;
- Currently using a Continuous Glucose Monitoring (CGM) system;
- HbA1c ≤ 8.5 % at screening;
- A minimum weight of 50kg;
- eGFR ≥ 60 mL/min/1.73m²
- Able to provide written informed consent approved by an Institutional Review Board (IRB).
Exclusion
- History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
- History of pancreatitis, medullary thyroid carcinoma and/or liver disease;
- Clinically significant diagnosis of anemia;
- Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight less than 50kg;
- Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
- Current or recent (within 1 month of screening) use of diabetes medications other than insulin;
- Women who are pregnant or lactating/breastfeeding;
- Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
- Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.
Key Trial Info
Start Date :
July 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04779645
Start Date
July 31 2021
End Date
December 31 2025
Last Update
June 10 2025
Active Locations (1)
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1
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037