ID

34681

Description

Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01189422

Link

https://clinicaltrials.gov/show/NCT01189422

Keywords

Versions (1)
  1. 1/23/19 1/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT01189422

English

Eligibility Type 1 Diabetes Mellitus NCT01189422

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
Description

Randomization | Sign or Symptom Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0011849
diagnosis of type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
currently receiving insulin therapy
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
detectable fasting or stimulated c-peptide level at screening
Description

Fasting C-peptide level Detectable | C-peptide level Stimulated Detectable

Data type

boolean

Alias
UMLS CUI [1,1]
C2208720
UMLS CUI [1,2]
C3830527
UMLS CUI [2,1]
C0202100
UMLS CUI [2,2]
C1948023
UMLS CUI [2,3]
C3830527
one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies
Description

Autoantibody test Result Positive | ICA512 autoantibody | IA-2 autoantibody | Glutamic Acid Decarboxylase Autoantibodies | Insulin autoantibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1272321
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0382981
UMLS CUI [3]
C0663193
UMLS CUI [4,1]
C0017785
UMLS CUI [4,2]
C0004358
UMLS CUI [5]
C1275890
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
Description

Medical condition Interferes with Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
previous treatment with monoclonal antibody
Description

Monoclonal Antibody Therapy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0279694
UMLS CUI [1,2]
C0205156
current treatment with oral antidiabetic agents
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
evidence of active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT01189422

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Randomization | Sign or Symptom Diabetes Mellitus
Item
randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
boolean
C0034656 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime
Item
currently receiving insulin therapy
boolean
C0557978 (UMLS CUI [1])
Fasting C-peptide level Detectable | C-peptide level Stimulated Detectable
Item
detectable fasting or stimulated c-peptide level at screening
boolean
C2208720 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0202100 (UMLS CUI [2,1])
C1948023 (UMLS CUI [2,2])
C3830527 (UMLS CUI [2,3])
Autoantibody test Result Positive | ICA512 autoantibody | IA-2 autoantibody | Glutamic Acid Decarboxylase Autoantibodies | Insulin autoantibody
Item
one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies
boolean
C1272321 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0382981 (UMLS CUI [2])
C0663193 (UMLS CUI [3])
C0017785 (UMLS CUI [4,1])
C0004358 (UMLS CUI [4,2])
C1275890 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Medical condition Interferes with Completion of clinical trial
Item
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])
Monoclonal Antibody Therapy Previous
Item
previous treatment with monoclonal antibody
boolean
C0279694 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Antidiabetics Oral
Item
current treatment with oral antidiabetic agents
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Communicable Disease
Item
evidence of active infection
boolean
C0009450 (UMLS CUI [1])
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