ID

22877

Descripción

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

Palabras clave

Versiones (1)
  1. 13/6/17 13/6/17 -
Subido en

13 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02004886

Inglés

Eligibility Type 2 Diabetes Mellitus NCT02004886

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Descripción

type 2 diabetes

Tipo de datos

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])
Descripción

antidiabetics, insulin, thiazolidinediones

Tipo de datos

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
Descripción

gender, childbearing potential, postmenopausal, female sterilization

Tipo de datos

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
Descripción

BMI

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

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

type 1 diabetes

Tipo de datos

boolean

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

ketoacidosis, diabetic retinopathy, nephropathy, neuropathy

Tipo de datos

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)
Descripción

combination anti-hyperglycemic therapy, insulin or thiazolidinediones

Tipo de datos

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
Descripción

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

Tipo de datos

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)
Descripción

hiv, aids

Tipo de datos

boolean

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

gastrointestinal disorder, extensive bowel or gastric surgery

Tipo de datos

boolean

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

cardiovascular disease

Tipo de datos

boolean

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

history of neoplastic disease

Tipo de datos

boolean

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

hepatic disease

Tipo de datos

boolean

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

seizures, epilepsy, other neurologic disease

Tipo de datos

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
Descripción

myelodysplastic disorder, hematological disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1301355
UMLS CUI [2]
C0018939
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02004886

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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