drugset / Trial / NCT03117998
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Volagidemab | Monoclonal antibody | 35 mg | Subcutaneous |
| Subject | Volagidemab | Monoclonal antibody | 70 mg | Subcutaneous |