Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
- Conditions
- Health Condition 1: null- Recent Onset Type 1 Diabetes Mellitus
- Registration Number
- CTRI/2009/091/000916
- Lead Sponsor
- MacroGenics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Subjects must meet all of the following criteria:
1. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA)
criteria
2. Written informed consent obtained from the subject (assent will be obtained for subjects
under age 18 years, according to all applicable regulations) including consent for the use of
research-related health information at screening
3. Randomization on Study Day 0 within 12 weeks of first visit to any physician for
symptoms or signs of diabetes
4. Requires insulin for T1DM or has required insulin at some time between diagnosis and
administration of study drug
5. Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable
range of the assay) at screening
6. Diagnosis of T1DM as evidenced by one positive result on testing for any of the following
antibodies at screening:
a. Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),
b. Glutamic acid decarboxylase (GAD) autoantibodies, or
c. Insulin autoantibodies (in subjects on insulin for more than 2 weeks, IA-2 or GAD
must be positive)
7. Subjects 8?35 years old
8. Body weight > 36 Kg
9. BSA ≤2.4 m2 (Interactive Voice Response System [IVRS] will be used to calculate BSA
using the Mosteller formula1)
10. Sexually active females, unless surgically sterile, must be willing to use 2 forms of
contraception through the end of the study (Study Day 728). Acceptable forms of
contraception for female subjects include: oral, transdermal, injectable or implanted
contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide,
cervical cap, use of a condom by the sexual partner, or sterile sexual partner. Abstinence is
an acceptable form of contraception only if it is the subject?s pre-existing method of
contraception. Male subjects with partners of child-bearing potential should use barrier
contraception in addition to having their partners use another method of contraception
11. Willing to forego other forms of experimental treatment during the study
Subjects must have none of the following:
1. Prior administration of a monoclonal antibody?within the 1 year before randomization
at Study Day 0
2. Participation in any type of therapeutic drug or vaccine clinical trial within the last 12
weeks before randomization at Study Day 0
3. Any medical condition that, in the opinion of the investigator, would interfere with safe
completion of the trial
4. Pregnant females or lactating females who intend to provide their own breast milk to the
baby during the study
5. Prior murine OKT®3 treatment or other anti-CD3 treatment
6. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any
other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
7. Current treatment with oral antidiabetic agents
8. Current or planned therapy with inhaled insulin, if it becomes available
9. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of
ischemic heart disease or other serious cardiac disease as described in New York Heart
Association (NYHA) Class III or IV criteria within the 12 weeks before randomization
(See Appendix E)
10. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral
vascular disease or cerebrovascular disease
11. Untreated hypothyroidism or active Graves? disease at Study Day 0
12. Eczema, asthma or severe atopic disease requiring treatment, including topical or
inhaled corticosteroids, within the 12 weeks before randomization
13. Treatment with systemic glucocorticoid therapy by oral, intravenous (IV), intramuscular
(IM), or inhaled route within 12 weeks before randomization; patients who are likely to
require treatment with systemic corticosteroids during the trial are also excluded
14. Evidence of active infection
15. History of or positive test for human immunodeficiency virus (HIV)
16. Positive immunoglobulin M (IgM) test for hepatitis A
17. History of or positive test for hepatitis B, C, or D
18. Total bilirubin 1.5 x upper limit of normal (ULN)
19. AST or ALT 1.5 x ULN
20. Evidence of active or latent tuberculosis (TB), which may include a positive purified
protein derivative (PPD) skin test result; a chest X-ray consistent with TB or household
contact with a person with active TB, unless appropriate isoniazid (INH) prophylaxis for
tuberculosis (TB) was previously given
21. Vaccination with a live virus or organism within the 8 weeks before randomization
continuing through Week 52 of the study.
? Influenza vaccinations with a killed virus, including booster vaccinations, within 4
weeks before or after each dosing cycle.
? Vaccination with other antigens or killed organisms within 8 weeks before or after
each dosing cycle
22. Any infectious mononucleosis-like illness within the 6 months before randomization
23. Serologic or clinical evidence of acute infection with Epstein-Barr virus (EBV),
including a positive Epstein-Barr virus (EBV) immunoglobulin M (IgM). (Viral load
does not have to
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subjects total daily insulin usage and his/her HbA1c levels.Timepoint: Not Applicable
- Secondary Outcome Measures
Name Time Method â?¢Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subjects total daily insulin usage and his/her HbA1c levels <br/ ><br> <br/ ><br>C-peptide secretory responses, as defined by the total area under the curve of the C-peptide response to a mixed meal <br/ ><br>Timepoint: Not Applicable