Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes (SUBCUE)
This study has been terminated.
Sponsor:
MacroGenics
Collaborator:
Eli Lilly and Company
Information provided by:
MacroGenics
ClinicalTrials.gov Identifier:
NCT01189422
First received: August 25, 2010
Last updated: February 1, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: teplizumab or placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| 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 |
Resource links provided by NLM:
Further study details as provided by MacroGenics:
Primary Outcome Measures:
- Dose regimen [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]Define and evaluate dose regimen based on AEs, PD response and drug levels.
| Estimated Enrollment: | 71 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Segment 1: 3 Arms |
Drug: teplizumab or placebo
infusion or injection
|
| Experimental: Segment 2: 4 Arms |
Drug: teplizumab or placebo
infusion or injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Anastasia G. Daifotis, MD, Clinical Development, MacroGenics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01189422 History of Changes |
| Other Study ID Numbers: | CP-MGA031-06 |
| Study First Received: | August 25, 2010 |
| Last Updated: | February 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MacroGenics:
|
Type 1 Diabetes Mellitus T1DM |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013