Criteria Fulfill
Item
subjects must meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diabetes Mellitus Sign or Symptom
Item
1. enrollment (segment #1) or randomization (segment #2) on study day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. study day 0 is the first day of study drug dosing.
boolean
C0011849 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
2. diagnosis of type 1 diabetes mellitus, according to the american diabetes association (ada) criteria
boolean
C0011854 (UMLS CUI [1])
Insulin injection Therapy Patient need for
Item
3. requirement for injected insulin therapy
boolean
C0199782 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Fasting C-peptide level Detectable | C-peptide stimulation test Positive
Item
4. have a detectable fasting or stimulated c-peptide level (above the lower limit of detection of the assay)
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0430183 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Antibody test Positive
Item
5. one positive result on testing for any of the following antibodies:
boolean
C0580327 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
autoantibodies to islet cells | ICA512
Item
1. islet-cell autoantibodies (ica512/ia-2),
boolean
C2097865 (UMLS CUI [1])
C0380315 (UMLS CUI [2])
Glutamic Acid Decarboxylase Autoantibodies
Item
2. glutamic acid decarboxylase autoantibodies, or
boolean
C0017785 (UMLS CUI [1,1])
C0004358 (UMLS CUI [1,2])
Insulin autoantibody | Insulin regime
Item
3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
boolean
C1275890 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
Gender
Item
6. male or female
boolean
C0079399 (UMLS CUI [1])
Age Group
Item
7. subject must be in one of the following age groups:
boolean
C0001779 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Age
Item
age 18-35 years
boolean
C0001779 (UMLS CUI [1])
Age
Item
age 12-17 years pending approval by data monitoring committee
boolean
C0001779 (UMLS CUI [1])
Age
Item
age 8-11 years pending approval by data monitoring committee
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
8. body weight ≥ 36 kg
boolean
C0005910 (UMLS CUI [1])
Criteria None
Item
subjects must have none of the following:
boolean
C0243161 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Monoclonal Antibody Therapy Preventing Disease Response | Monoclonal Antibody Therapy Interferes with Disease Response | MGA031
Item
1. prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at study day 0 -- that could potentially prevent or confound a therapeutic response to mga031
boolean
C0279694 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C0279694 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C2987612 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Vaccines
Item
2. participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Medical condition Interferes with Completion of clinical trial
Item
3. any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
4. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Muromonab-CD3
Item
5. prior murine okt®3 treatment at any time before enrollment or randomization
boolean
C0085379 (UMLS CUI [1])
Exenatide | Exenatide Planned | Pharmaceutical Preparations Stimulating Pancreatic beta cell Regeneration | Pharmaceutical Preparations Stimulating Insulin secretion
Item
6. current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
boolean
C0167117 (UMLS CUI [1])
C0167117 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1948023 (UMLS CUI [3,2])
C0030281 (UMLS CUI [3,3])
C0034963 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C1948023 (UMLS CUI [4,2])
C1256369 (UMLS CUI [4,3])
Insulin Inhaled | Insulin Inhaled Planned
Item
7. current or planned therapy with inhaled insulin
boolean
C0021641 (UMLS CUI [1,1])
C0001559 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0001559 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Heart failure Uncompensated | Fluid overload | Myocardial Infarction | Myocardial Ischemia | Heart Disease Serious
Item
8. uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
boolean
C0018801 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
C0546817 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Epilepsy | Malignant Neoplasms | Cystic Fibrosis | Anemia, Sickle Cell | Neuropathy | Peripheral Vascular Diseases | Cerebrovascular Disorders
Item
9. history of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
boolean
C0014544 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0010674 (UMLS CUI [3])
C0002895 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0085096 (UMLS CUI [6])
C0007820 (UMLS CUI [7])
Hypothyroidism Treatment required for | Graves Disease
Item
10. newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active graves' disease
boolean
C0020676 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0018213 (UMLS CUI [2])
Eczema Treatment required for | Asthma Treatment required for | Atopic disorders Severe Treatment required for
Item
11. eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
boolean
C0013595 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0004096 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0947961 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332121 (UMLS CUI [3,3])
Communicable Disease | Fever
Item
12. evidence of active infection, such as fever ≥ 38.0 degrees celsius (100.5 degrees fahrenheit)
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
HIV Infection | HIV Infection Suspected
Item
13. known or suspected infection with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Hepatitis B | Hepatitis C
Item
14. evidence of active hepatitis b (hbv) or hepatitis c virus (hcv)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Tuberculosis | Latent Tuberculosis
Item
15. evidence of active or latent tuberculosis
boolean
C0041296 (UMLS CUI [1])
C1609538 (UMLS CUI [2])
Live Vaccines | Live Vaccines Planned | Vaccine Antigen | Vaccines, Inactivated
Item
16. vaccination with a live virus within the 12 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. vaccination with an antigen or killed organism must not be given within 12 weeks before or planned within 8 weeks after each dosing cycle.
boolean
C0042211 (UMLS CUI [1])
C0042211 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1519887 (UMLS CUI [3])
C0042212 (UMLS CUI [4])
Illness Infectious Mononucleosis Similar
Item
17. any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
boolean
C0221423 (UMLS CUI [1,1])
C0021345 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
Epstein-Barr Virus Infection Evidence Serologic | Epstein-Barr Virus Infection Evidence Clinical
Item
18. serologic and clinical evidence of acute infection with epstein-barr virus (ebv)
boolean
C0149678 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0149678 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Cytomegalovirus Infection Evidence Serologic
Item
19. serologic evidence of acute infection with cytomegalovirus (cmv)
boolean
C0010823 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])