ID

16062

Description

The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02366377

Link

https://clinicaltrials.gov/show/NCT02366377

Keywords

  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 NCT02366377

Eligibility Type 2 Diabetes Mellitus NCT02366377

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 been treated with metformin for more than 8 weeks with dose more than 1500mg/day.
Description

Therapeutic procedure Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025598
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 Diseases 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

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02366377

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])
Therapeutic procedure Metformin
Item
patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
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 Diseases 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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