ID

22877

Description

A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005); ODM derived from: https://clinicaltrials.gov/show/NCT02004886

Link

https://clinicaltrials.gov/show/NCT02004886

Keywords

Versions (1)
  1. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT02004886

English

Eligibility Type 2 Diabetes Mellitus NCT02004886

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
not currently on antihyperglycemic agent (aha) or aha monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, pparγ agents])
Description

antidiabetics, insulin, thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0557978
UMLS CUI [3]
C1257987
male or a female of non-childbearing potential. women must be postmenopausal or premenopausal and documented surgically sterilized
Description

gender, childbearing potential, postmenopausal, female sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0232970
UMLS CUI [2,3]
C0015787
a body mass index (bmi) that is > 20 and ≤ 40 kg/m2
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
Description

ketoacidosis, diabetic retinopathy, nephropathy, neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0011884
UMLS CUI [3]
C0011881
UMLS CUI [4]
C0011882
treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
Description

combination anti-hyperglycemic therapy, insulin or thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1,1]
C0013218
UMLS CUI [1,2]
C0935929
UMLS CUI [2]
C0557978
UMLS CUI [3]
C1257987
oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
Description

oral corticosteroid therapy, digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies

Data type

boolean

Alias
UMLS CUI [1]
C0574135
UMLS CUI [2]
C0012265
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0003280
UMLS CUI [5]
C0039771
UMLS CUI [6]
C1979623
UMLS CUI [7]
C0003299
UMLS CUI [8]
C0021081
UMLS CUI [9]
C0003392
UMLS CUI [10]
C0721997
history of acquired immunodeficiency syndrome (aids) or human immunodeficiency virus (hiv)
Description

hiv, aids

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0001175
history of gastrointestinal problems or disorders or extensive bowel or gastric surgery
Description

gastrointestinal disorder, extensive bowel or gastric surgery

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0192573
UMLS CUI [2,2]
C0205231
history of significant or unstable cardiovascular disease
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
history of neoplastic disease
Description

history of neoplastic disease

Data type

boolean

Alias
UMLS CUI [1]
C2735088
history of hepatic disease
Description

hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
history of seizures, epilepsy or other neurologic disease
Description

seizures, epilepsy, other neurologic disease

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0027765
history of myelodysplastic or pre-leukemic disorders or other severe hematological disorder
Description

myelodysplastic disorder, hematological disorder

Data type

boolean

Alias
UMLS CUI [1]
C1301355
UMLS CUI [2]
C0018939
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02004886

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetes
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
antidiabetics, insulin, thiazolidinediones
Item
not currently on antihyperglycemic agent (aha) or aha monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, pparγ agents])
boolean
C0935929 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
gender, childbearing potential, postmenopausal, female sterilization
Item
male or a female of non-childbearing potential. women must be postmenopausal or premenopausal and documented surgically sterilized
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C0015787 (UMLS CUI [2,3])
BMI
Item
a body mass index (bmi) that is > 20 and ≤ 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
type 1 diabetes
Item
history of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
ketoacidosis, diabetic retinopathy, nephropathy, neuropathy
Item
history of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
boolean
C0011880 (UMLS CUI [1])
C0011884 (UMLS CUI [2])
C0011881 (UMLS CUI [3])
C0011882 (UMLS CUI [4])
combination anti-hyperglycemic therapy, insulin or thiazolidinediones
Item
treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
boolean
C0013218 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
oral corticosteroid therapy, digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
Item
oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
boolean
C0574135 (UMLS CUI [1])
C0012265 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0003280 (UMLS CUI [4])
C0039771 (UMLS CUI [5])
C1979623 (UMLS CUI [6])
C0003299 (UMLS CUI [7])
C0021081 (UMLS CUI [8])
C0003392 (UMLS CUI [9])
C0721997 (UMLS CUI [10])
hiv, aids
Item
history of acquired immunodeficiency syndrome (aids) or human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
gastrointestinal disorder, extensive bowel or gastric surgery
Item
history of gastrointestinal problems or disorders or extensive bowel or gastric surgery
boolean
C0017178 (UMLS CUI [1])
C0192573 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
cardiovascular disease
Item
history of significant or unstable cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
history of neoplastic disease
Item
history of neoplastic disease
boolean
C2735088 (UMLS CUI [1])
hepatic disease
Item
history of hepatic disease
boolean
C0023895 (UMLS CUI [1])
seizures, epilepsy, other neurologic disease
Item
history of seizures, epilepsy or other neurologic disease
boolean
C0036572 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
myelodysplastic disorder, hematological disorder
Item
history of myelodysplastic or pre-leukemic disorders or other severe hematological disorder
boolean
C1301355 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial