drugset / Trial / NCT02455011

Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus

NCT02455011

Phase 1/2 Completed 75 enrolled REMD Biotherapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects. The study will be conducted at multiple sites in the United States and will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve, controlled with diet and exercise or treated with oral antidiabetic medications.

Timeline

Start
2015-09
Primary completion
2018-01
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Volagidemab Monoclonal antibody Subcutaneous