ID

38801

Descripción

Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01947855

Link

https://clinicaltrials.gov/show/NCT01947855

Palabras clave

Versiones (1)
  1. 5/11/19 5/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01947855

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT01947855

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes mellitus prior to informed consent
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:
Descripción

Gender | Diet therapy | Exercise

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
Descripción

Pharmaceutical Preparations Absent | Antidiabetics Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
Descripción

Pretreatment | Antidiabetics Oral Quantity | Exception Sulfonylurea | Exception Thiazolidinediones | Diabetes Therapy unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3539076
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038766
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1257987
UMLS CUI [5,1]
C3274787
UMLS CUI [5,2]
C0442739
glycosylated haemoglobin (hba1c) at visit 1 (screening)
Descripción

HbA1c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
for patients without antidiabetic therapy : hba1c >=7.0 to =<10.0%
Descripción

Diabetes Therapy Absent | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0474680
for patients with one oral antidiabetic drug : hba1c >=7.0 to =<9.5%
Descripción

Antidiabetics Oral Quantity | Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0474680
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/l)
Descripción

Hyperglycemia Uncontrolled | Glucose level

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0428548
impaired renal function, defined as estimated glomerular filtration rate (egfr) <60 ml/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (mdrd) formula)
Descripción

Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD formula | Renal Insufficiency Severe MDRD formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205081
UMLS CUI [3,3]
C3839656
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C3839656
acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent
Descripción

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
Descripción

Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum alkaline phosphatase raised

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C1314665
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01947855

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes mellitus prior to informed consent
boolean
C0011860 (UMLS CUI [1])
Gender | Diet therapy | Exercise
Item
male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Pharmaceutical Preparations Absent | Antidiabetics Absent
Item
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
boolean
C0013227 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pretreatment | Antidiabetics Oral Quantity | Exception Sulfonylurea | Exception Thiazolidinediones | Diabetes Therapy unchanged
Item
pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
boolean
C3539076 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1257987 (UMLS CUI [4,2])
C3274787 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
HbA1c
Item
glycosylated haemoglobin (hba1c) at visit 1 (screening)
boolean
C0019018 (UMLS CUI [1])
Diabetes Therapy Absent | Hemoglobin A1c measurement
Item
for patients without antidiabetic therapy : hba1c >=7.0 to =<10.0%
boolean
C3274787 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Antidiabetics Oral Quantity | Hemoglobin A1c measurement
Item
for patients with one oral antidiabetic drug : hba1c >=7.0 to =<9.5%
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level
Item
uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/l)
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD formula | Renal Insufficiency Severe MDRD formula
Item
impaired renal function, defined as estimated glomerular filtration rate (egfr) <60 ml/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (mdrd) formula)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C3839656 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum alkaline phosphatase raised
Item
indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C1314665 (UMLS CUI [4])
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