NCT00920582Phase 3Terminated

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2012-04Actual

Enrollment · participants254Actual

Source updated2023-12-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Type 1 Diabetes Mellitus

Treatments or interventions studied

Teplizumab Herold RegimenBiologicalAlso known as MGA031
PlaceboDrug
Teplizumab 33.3% Herold RegimenBiologicalAlso known as MGA031
Teplizumab Curtailed Herold RegimenBiological

Primary outcomes · main study measures

measure: Proportion of Subjects With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.; timeFrame: 52 weeks after randomization; measure: Mean Change From Baseline in HbA1c Between Teplizumab and Placebo; timeFrame: 52 weeks after randomization

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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