Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes (SUBCUE)
Status and phase
Terminated
Phase 1
Conditions
Type 1 Diabetes Mellitus
Treatments
Drug: teplizumab or placebo
Details and patient eligibility
About
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.
Enrollment
1 patient
Sex
All
Ages
18 to 35 years old
Volunteers
No 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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
1 participants in 2 patient groups
Segment 1: 3 Arms
Experimental group
Treatment:
Drug: teplizumab or placebo
Segment 2: 4 Arms
Experimental group
Treatment:
Drug: teplizumab or placebo
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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