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A Randomized, Placebo-controlled, Double-blind, In-patient Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 Following a Single Dose in Subjects With Type 1 Diabetes Mellitus

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Trial Profile

A Randomized, Placebo-controlled, Double-blind, In-patient Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 Following a Single Dose in Subjects With Type 1 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Volagidemab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors REMD Biotherapeutics

    • Most Recent Events

    • 15 Sep 2017 Results (n=17) of interim analysis presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 13 Jun 2017 Primary endpoint (Changes from baseline in 24-hour insulin requirements on Day 1 relative to the two 24 hour periods post-treatment on Day 4, between the REMD-477 and placebo treated subjects, needed to maintain targeted glycemic control.) has been met as per the results presented at the 77th Annual Scientific Sessions of the American Diabetes Association.
    • 13 Jun 2017 Results (n=17) presented at the 77th Annual Scientific Sessions of the American Diabetes Association

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