ID

37329

Descrição

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02227849

Link

https://clinicaltrials.gov/show/NCT02227849

Palavras-chave

Versões (1)
  1. 17/07/2019 17/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02227849

Inglês

Eligibility Type 2 Diabetes Mellitus NCT02227849

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who has been receiving a stable dose and regimen of glp-1 analogue over 12 weeks before administration of investigational dug
Descrição

GLP-1 Analogue Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3273809
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Descrição

Diet therapy Diabetes Mellitus | Therapeutic exercise Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C1455811
UMLS CUI [2,2]
C0011849
patients with hba1c of ≥7.0% and <10.5%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Descrição

Absence Antidiabetics Illicit

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C0332266
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (cushing's syndrome, acromegaly, etc.)
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes mellitus associated with pancreatic disease | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0342270
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0010481
UMLS CUI [5]
C0001206
patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
Descrição

Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease Stage | Diabetic Neuropathy Serious

Tipo de dados

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]
C1306673
UMLS CUI [4,1]
C0011882
UMLS CUI [4,2]
C0205404
patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
Descrição

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
patients with systolic blood pressure of ≥160 mmhg or diastolic blood pressure of
Descrição

Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
≥100 mmhg
Descrição

ID.9

Tipo de dados

boolean

patients with serious renal or hepatic disease
Descrição

Kidney Disease Serious | Liver disease Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
patients with egfr of <45 ml/min/1.73 m2
Descrição

Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3811844
patients who are the excessive alcohol addicts
Descrição

Alcohol addiction Excessive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0442802
patients requiring insulin therapy
Descrição

Patient need for Insulin regime

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0557978
patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Descrição

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02227849

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
GLP-1 Analogue Dose Stable
Item
patients who has been receiving a stable dose and regimen of glp-1 analogue over 12 weeks before administration of investigational dug
boolean
C3273809 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Diet therapy Diabetes Mellitus | Therapeutic exercise Diabetes Mellitus
Item
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
boolean
C0012159 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C1455811 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
patients with hba1c of ≥7.0% and <10.5%
boolean
C0474680 (UMLS CUI [1])
Absence Antidiabetics Illicit
Item
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
boolean
C0332197 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes mellitus associated with pancreatic disease | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (cushing's syndrome, acromegaly, etc.)
boolean
C0011854 (UMLS CUI [1])
C0342270 (UMLS CUI [2])
C0271640 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
Complications of Diabetes Mellitus Severe | Proliferative diabetic retinopathy | Kidney Disease Stage | Diabetic Neuropathy Serious
Item
patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0154830 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C1306673 (UMLS CUI [3,2])
C0011882 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Systolic Pressure | Diastolic blood pressure
Item
patients with systolic blood pressure of ≥160 mmhg or diastolic blood pressure of
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
ID.9
Item
≥100 mmhg
boolean
Kidney Disease Serious | Liver disease Serious
Item
patients with serious 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])
Estimated Glomerular Filtration Rate
Item
patients with egfr of <45 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Alcohol addiction Excessive
Item
patients who are the excessive alcohol addicts
boolean
C0001973 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
Patient need for Insulin regime
Item
patients requiring insulin therapy
boolean
C0686904 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unwilling
Item
patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
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