ID

34742

Description

Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02346175

Link

https://clinicaltrials.gov/show/NCT02346175

Keywords

Versions (1)
  1. 1/25/19 1/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 25, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT02346175

English

Eligibility Type 2 Diabetes Mellitus NCT02346175

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi:20-35kg/m2;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ecg) at screening;
Description

Stable status Medical Physical Examination | Medical stable status Medical History | Stable status Medical Laboratory Results | Stable status Medical Vital signs assessment | Stable status Medical 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205476
UMLS CUI [3,3]
C1254595
UMLS CUI [4,1]
C0205360
UMLS CUI [4,2]
C0205476
UMLS CUI [4,3]
C0150404
UMLS CUI [5,1]
C0205360
UMLS CUI [5,2]
C0205476
UMLS CUI [5,3]
C0430456
on a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (fpg) concentration lower than 13.9 mmol/l at baseline;
Description

Hypoglycemic Agents Stable | Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0583513
stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (hba1c) between 7.0% and 10.0%.
Description

Hypoglycemic Agents Stable | Oral medication Single | Metformin | Sulfonylurea | Other Coding | Benzoic acid or derivative | Dipeptidyl-Peptidase IV Inhibitors | alpha-Glucosidase Inhibitors | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0205171
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5]
C3846158
UMLS CUI [6]
C0578497
UMLS CUI [7]
C1827106
UMLS CUI [8]
C1299007
UMLS CUI [9]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
Description

Complications of Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent | Hypoglycaemic episode Severe Repeated

Data type

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0011854
UMLS CUI [3,1]
C0745153
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0205341
pregnancy or breastfeeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant acute or chronic medical illness, including renal impairment, or recent surgery;
Description

Illness Significant | Chronic disease | Renal Insufficiency | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0008679
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0543467
donation of blood or plasma within the 4 weeks prior to the start of the study;
Description

Blood Donation | Plasma Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02346175

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi:20-35kg/m2;
boolean
C1305855 (UMLS CUI [1])
Stable status Medical Physical Examination | Medical stable status Medical History | Stable status Medical Laboratory Results | Stable status Medical Vital signs assessment | Stable status Medical 12 lead ECG
Item
medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ecg) at screening;
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0205476 (UMLS CUI [3,2])
C1254595 (UMLS CUI [3,3])
C0205360 (UMLS CUI [4,1])
C0205476 (UMLS CUI [4,2])
C0150404 (UMLS CUI [4,3])
C0205360 (UMLS CUI [5,1])
C0205476 (UMLS CUI [5,2])
C0430456 (UMLS CUI [5,3])
Hypoglycemic Agents Stable | Plasma fasting glucose measurement
Item
on a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (fpg) concentration lower than 13.9 mmol/l at baseline;
boolean
C0020616 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
Hypoglycemic Agents Stable | Oral medication Single | Metformin | Sulfonylurea | Other Coding | Benzoic acid or derivative | Dipeptidyl-Peptidase IV Inhibitors | alpha-Glucosidase Inhibitors | Hemoglobin A1c measurement
Item
stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (hba1c) between 7.0% and 10.0%.
boolean
C0020616 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0578497 (UMLS CUI [6])
C1827106 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0474680 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Complications of Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent | Hypoglycaemic episode Severe Repeated
Item
history of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
boolean
C0342257 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0745153 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Significant | Chronic disease | Renal Insufficiency | Operative Surgical Procedures
Item
significant acute or chronic medical illness, including renal impairment, or recent surgery;
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Blood Donation | Plasma Donation
Item
donation of blood or plasma within the 4 weeks prior to the start of the study;
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial