A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

Description

Eligibility

Age range

1–25 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Teplizumab

  Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

• Other
  Placebo

  Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion

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