NCT03117998

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

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Multiple Doses of REMD-477 in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: REMD Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	REMD-477	Administered as repeated SC doses in subjects with Type 1 Diabetes
BIOLOGICAL	Placebo Comparator	Administered as a repeated SC doses in subjects with Type 1 Diabetes

Timeline

• Start date: 2017-09-19
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2017-04-18
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study