ID

34742

Descripción

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

Palabras clave

Versiones (1)
  1. 25/1/19 25/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

25 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02346175

Inglés

Eligibility Type 2 Diabetes Mellitus NCT02346175

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Body mass index

Tipo de datos

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;
Descripción

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

Tipo de datos

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;
Descripción

Hypoglycemic Agents Stable | Plasma fasting glucose measurement

Tipo de datos

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%.
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

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

Tipo de datos

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;
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

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

Tipo de datos

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;
Descripción

Blood Donation | Plasma Donation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02346175

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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