Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes (SUBCUE)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
teplizumab or placebo
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, T1DM
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Segment 1: 3 Arms
Segment 2: 4 Arms
Arm Description
Outcomes
Primary Outcome Measures
Dose regimen
Define and evaluate dose regimen based on AEs, PD response and drug levels.
Secondary Outcome Measures
Full Information
NCT ID
NCT01189422
First Posted
August 25, 2010
Last Updated
February 4, 2022
Sponsor
MacroGenics
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01189422
Brief Title
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, T1DM
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Segment 1: 3 Arms
Arm Type
Experimental
Arm Title
Segment 2: 4 Arms
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
teplizumab or placebo
Intervention Description
infusion or injection
Primary Outcome Measure Information:
Title
Dose regimen
Description
Define and evaluate dose regimen based on AEs, PD response and drug levels.
Time Frame
91 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
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