Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01189422

Acronym

SUBCUE

Enrollment

Registered

2010-08-26

Start date

2010-08-31

Completion date

2011-02-28

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, T1DM

Brief summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.

Interventions

DRUGteplizumab or placebo

infusion or injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Inclusion criteria

* Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes * Diagnosis of type 1 diabetes mellitus * Currently receiving insulin therapy * Detectable fasting or stimulated C-peptide level at screening * One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies

Exclusion criteria

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial * Previous treatment with monoclonal antibody * Current treatment with oral antidiabetic agents * Evidence of active infection

Design outcomes

Primary

Measure	Time frame	Description
Dose regimen	91 days	Define and evaluate dose regimen based on AEs, PD response and drug levels.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026