ID

32937

Descripción

An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01022112

Link

https://clinicaltrials.gov/show/NCT01022112

Palabras clave

Versiones (1)
  1. 21/11/18 21/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

21 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01022112

Inglés

Eligibility Type 2 Diabetes Mellitus NCT01022112

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged from 20 to 80 years inclusive on the day of informed consent;
Descripción

Age | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
patients with hba1c of ≥6.5% and ≤9.5% (according to the japan diabetic society [jds] criteria) on the start day of the run-in period;
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.);
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Disease | Secondary diabetes mellitus | Acromegaly | Cushing Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0030286
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0001206
UMLS CUI [5]
C0010481
past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
Descripción

Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease TNM clinical staging | Diabetic Ketoacidosis | Diabetic Neuropathy Serious

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0154830
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C0011880
UMLS CUI [5,1]
C0011882
UMLS CUI [5,2]
C0205404
fasting blood glucose of >270 mg/dl on the start day of the run-in period or at week 2 of the run-in period;
Descripción

Fasting blood glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428568
egfr of <60 ml/min/1.73 m2 on the start day of the run-in period;
Descripción

Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
Descripción

Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
history of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
Descripción

Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0007820
concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
Descripción

Kidney Disease Serious | Liver disease Serious | Hospitalization Required | Surgical intervention Required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C1708385
UMLS CUI [4,1]
C0549433
UMLS CUI [4,2]
C1514873
past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
Descripción

Malignant Neoplasms | Exception Relapse Free of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0035020
UMLS CUI [2,3]
C0332296
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
Descripción

Drug Allergy | Shock | Symptoms Anaphylactoid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0036974
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1706805
pregnant women, lactating mothers, or women of childbearing potential;
Descripción

Pregnancy | Breast Feeding | Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Descripción

Condition Study Subject Participation Status Ineligible

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1512714
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Eligibility Type 2 Diabetes Mellitus NCT01022112

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
aged from 20 to 80 years inclusive on the day of informed consent;
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
patients with hba1c of ≥6.5% and ≤9.5% (according to the japan diabetic society [jds] criteria) on the start day of the run-in period;
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Disease | Secondary diabetes mellitus | Acromegaly | Cushing Syndrome
Item
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, cushing's syndrome, etc.);
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0030286 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
C0010481 (UMLS CUI [5])
Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease TNM clinical staging | Diabetic Ketoacidosis | Diabetic Neuropathy Serious
Item
past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage iii or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0154830 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0011880 (UMLS CUI [4])
C0011882 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
Fasting blood glucose measurement
Item
fasting blood glucose of >270 mg/dl on the start day of the run-in period or at week 2 of the run-in period;
boolean
C0428568 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
egfr of <60 ml/min/1.73 m2 on the start day of the run-in period;
boolean
C3811844 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders
Item
history of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
Kidney Disease Serious | Liver disease Serious | Hospitalization Required | Surgical intervention Required
Item
concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
boolean
C0022658 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1708385 (UMLS CUI [3])
C0549433 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Relapse Free of
Item
past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
Drug Allergy | Shock | Symptoms Anaphylactoid
Item
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
boolean
C0013182 (UMLS CUI [1])
C0036974 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C1706805 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant women, lactating mothers, or women of childbearing potential;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Condition Study Subject Participation Status Ineligible
Item
any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
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