drugset / Trial / NCT03117998

Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

NCT03117998

Phase 2 Completed 154 enrolled REMD Biotherapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide \< 0.7 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 150 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.

Timeline

Start
2017-09-19
Primary completion
2021-03-05
Completion
2021-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Volagidemab Monoclonal antibody 35 mg Subcutaneous
Subject Volagidemab Monoclonal antibody 70 mg Subcutaneous