ID

33693

Description

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01581658

Link

https://clinicaltrials.gov/show/NCT01581658

Keywords

Versions (1)
  1. 12/19/18 12/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01581658

English

Eligibility Diabetes Mellitus, Type 2 NCT01581658

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes patients
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
glycosylated haemoglobin>= 6.1% (japan diabetes society)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 ml/min/1.73m2
Description

GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C2170215
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any evidence of significant disease (other than renal impairment)
Description

Disease Significant | Exception Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1565489
moderate and severe concurrent liver function impairment
Description

Liver Dysfunction Moderate | Liver Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
gastrointestinal tract surgery, that might affect absorption and elimination of drugs
Description

Gastrointestinal Surgical Procedure Affecting Drug absorption | Gastrointestinal Surgical Procedure Affecting Drug elimination

Data type

boolean

Alias
UMLS CUI [1,1]
C0524722
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683141
diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
Description

CNS disorder | Epilepsy | Mental disorders | Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0027765
chronic or relevant acute infections
Description

Chronic infectious disease | Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0009450
participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01581658

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes patients
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin>= 6.1% (japan diabetes society)
boolean
C0474680 (UMLS CUI [1])
GFR estimation by MDRD
Item
estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 ml/min/1.73m2
boolean
C2170215 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Significant | Exception Renal Insufficiency
Item
any evidence of significant disease (other than renal impairment)
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1565489 (UMLS CUI [2,2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
moderate and severe concurrent liver function impairment
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure Affecting Drug absorption | Gastrointestinal Surgical Procedure Affecting Drug elimination
Item
gastrointestinal tract surgery, that might affect absorption and elimination of drugs
boolean
C0524722 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683141 (UMLS CUI [2,3])
CNS disorder | Epilepsy | Mental disorders | Nervous system disorder
Item
diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Chronic infectious disease | Communicable Diseases
Item
chronic or relevant acute infections
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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