# The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

> **NCT00385697** · PHASE2,PHASE3 · COMPLETED · sponsor: **MacroGenics** · enrollment: 554 (actual)

## Conditions studied

- Type 1 Diabetes Mellitus

## Interventions

- **BIOLOGICAL:** Teplizumab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00385697
- **Lead sponsor:** MacroGenics
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-10
- **Primary completion:** 2010-06
- **Final completion:** 2011-08
- **Target enrollment:** 554 (ACTUAL)
- **Last updated:** 2023-12-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00385697

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00385697, "The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00385697. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
