ID

37329

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02227849

Keywords

versioni (1)
  1. 17/07/19 17/07/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 luglio 2019

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02227849

Inglese

Eligibility Type 2 Diabetes Mellitus NCT02227849

1 moduli  
Inclusion Criteria
Descrizione

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
Descrizione

GLP-1 Analogue Dose Stable

Tipo di dati

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
Descrizione

Diet therapy Diabetes Mellitus | Therapeutic exercise Diabetes Mellitus

Tipo di dati

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%
Descrizione

Hemoglobin A1c measurement

Tipo di dati

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
Descrizione

Absence Antidiabetics Illicit

Tipo di dati

boolean

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

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.)
Descrizione

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

Tipo di dati

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)
Descrizione

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

Tipo di dati

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
Descrizione

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Tipo di dati

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
Descrizione

Systolic Pressure | Diastolic blood pressure

Tipo di dati

boolean

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

ID.9

Tipo di dati

boolean

patients with serious renal or hepatic disease
Descrizione

Kidney Disease Serious | Liver disease Serious

Tipo di dati

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
Descrizione

Estimated Glomerular Filtration Rate

Tipo di dati

boolean

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

Alcohol addiction Excessive

Tipo di dati

boolean

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

Patient need for Insulin regime

Tipo di dati

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
Descrizione

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unwilling

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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