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This study evaluates a glucagon receptor antagonist called REMD-477 compared with placebo (an inactive drug) in patients with type 1 diabetes. People aged 18-65 who have had type 1 diabetes for more than 5 years and use an insulin pump and a continuous glucose monitoring system can take part. The study is in Phase 2 and is currently not recruiting but ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening; 2. 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; 3. 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; 4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria for \> 5 years; 5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump; 6. Currently using a Continuous Glucose Monitoring (CGM) system; 7. HbA1c ≤ 8.5 % at screening; 8. A minimum weight of 50kg; 9. eGFR ≥ 60 mL/min/1.73m² 10. Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: 1. 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; 2. History of pancreatitis, medullary thyroid carcinoma and/or liver disease; 3. Clinically significant diagnosis of anemia; 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight less than 50kg; 5. 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; 6. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; 7. Women who are pregnant or lactating/breastfeeding; 8. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 9. 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.