ID

16054

Description

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02366351

Link

https://clinicaltrials.gov/show/NCT02366351

Keywords

Versions (1)
  1. 6/27/16 6/27/16 -
Uploaded on

June 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02366351

English

Eligibility Type 2 Diabetes Mellitus NCT02366351

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a diagnosis of type 2 diabetes mellitus;
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hemoglobin a1c levels >=7.5% and <=10.5%;
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) 25 to 45 kg/m2;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
Description

Hypoglycemic Agents Patient untreated | Therapeutic procedure Hypoglycemic Agents Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0020616
UMLS CUI [2,3]
C0449238
Exclusion Criteria
Description

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.);
Description

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

Data type

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);
Description

Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease Staging of disease | Diabetic Ketoacidosis | Diabetic Neuropathies Serious

Data type

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]
C0449385
UMLS CUI [4]
C0011880
UMLS CUI [5,1]
C0011882
UMLS CUI [5,2]
C0205404
systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg on the start or end day of the run-in period;
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
history of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
Description

Myocardial Infarction | Angina, Unstable | Cerebrovascular Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0007820
past or current history of malignant tumor;
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
Description

Drug Allergy | anaphylaxis | Drug-induced anaphylactoid reaction

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0002792
UMLS CUI [3]
C0344178
pregnant women, lactating mothers, or women of childbearing potential;
Description

Pregnancy | Breast Feeding | Childbearing Potential

Data type

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).
Description

Condition Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02366351

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients must have a diagnosis of type 2 diabetes mellitus;
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c levels >=7.5% and <=10.5%;
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) 25 to 45 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Patient untreated | Therapeutic procedure Hypoglycemic Agents Duration
Item
patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
boolean
C0020616 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0020616 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | 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 Staging of disease | Diabetic Ketoacidosis | Diabetic Neuropathies 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])
C0449385 (UMLS CUI [3,2])
C0011880 (UMLS CUI [4])
C0011882 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
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 6 months before the start of the run-in period;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
Malignant Neoplasms
Item
past or current history of malignant tumor;
boolean
C0006826 (UMLS CUI [1])
Drug Allergy | anaphylaxis | Drug-induced anaphylactoid reaction
Item
past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
boolean
C0013182 (UMLS CUI [1])
C0002792 (UMLS CUI [2])
C0344178 (UMLS CUI [3])
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 Limited
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])
C0439801 (UMLS CUI [1,3])
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