Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— SUBCUE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189422
• Other study ID #: CP-MGA031-06
• Status: Terminated
• Phase: Phase 1
• Start date: August 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2022
• Source: MacroGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• teplizumab or placebo
infusion or injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MacroGenics	Eli Lilly and Company

Outcome

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