ID

37329

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.07.19 17.07.19 -
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See clinicaltrials.gov

Hochgeladen am

17. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02227849

Englisch

Eligibility Type 2 Diabetes Mellitus NCT02227849

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

GLP-1 Analogue Dose Stable

Datentyp

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
Beschreibung

Diet therapy Diabetes Mellitus | Therapeutic exercise Diabetes Mellitus

Datentyp

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%
Beschreibung

Hemoglobin A1c measurement

Datentyp

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
Beschreibung

Absence Antidiabetics Illicit

Datentyp

boolean

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

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.)
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Datentyp

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
Beschreibung

Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

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

ID.9

Datentyp

boolean

patients with serious renal or hepatic disease
Beschreibung

Kidney Disease Serious | Liver disease Serious

Datentyp

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
Beschreibung

Estimated Glomerular Filtration Rate

Datentyp

boolean

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

Alcohol addiction Excessive

Datentyp

boolean

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

Patient need for Insulin regime

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unwilling

Datentyp

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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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT02227849

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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