ID

29191

Beschrijving

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride; ODM derived from: https://clinicaltrials.gov/show/NCT00968812

Link

https://clinicaltrials.gov/show/NCT00968812

Trefwoorden

Versies (1)
  1. 05-03-18 05-03-18 -
Houder van rechten

See clinicaltrials.gov

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5 maart 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00968812

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00968812

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a diagnosis of type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
body mass index (bmi) >=22 to <=45 kg/m2, at screening
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
patients must be taking a stable dosage of metformin as monotherapy at screening
Beschrijving

Metformin Dosage Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
patients must have a hba1c between >=7% and <=9.5% at week 2
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
patients must have a fasting plasma glucose (fpg) <=270 mg/dl (15 mmol/l) at week -2
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients having prior exposure or known contraindication or suspected hypersensitivity to jnj-28431754, glimepiride, or metformin
Beschrijving

Exposure to JNJ-24831754 | Medical contraindication JNJ-24831754 | Hypersensitivity Suspected JNJ-24831754 | Exposure to Glimepiride | Medical contraindication Glimepiride | Hypersensitivity Suspected Glimepiride | Exposure to Metformin | Medical contraindication Metformin | Hypersensitivity Suspected Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2987596
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2987596
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0061323
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0061323
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0061323
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C0061323
UMLS CUI [7,1]
C0332157
UMLS CUI [7,2]
C0025598
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0025598
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0750491
UMLS CUI [9,3]
C0025598
history of diabetic ketoacidosis or type 1 diabetes mellitus
Beschrijving

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0011854
history of pancreas or beta-cell transplantation
Beschrijving

Pancreas Transplantation | Pancreas beta-cell transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0030275
UMLS CUI [2,1]
C0030281
UMLS CUI [2,2]
C0040732
history of active proliferative diabetic retinopathy
Beschrijving

Proliferative diabetic retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0154830
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
Beschrijving

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Datatype

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
Beschrijving

Kidney Disease Requirement Therapeutic immunosuppression | Dialysis | Kidney Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0022671
taken thiazolidinedione therapy in the past 16 weeks before screening
Beschrijving

Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C1257987
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00968812

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients must have a diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) >=22 to <=45 kg/m2, at screening
boolean
C1305855 (UMLS CUI [1])
Metformin Dosage Stable
Item
patients must be taking a stable dosage of metformin as monotherapy at screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
patients must have a hba1c between >=7% and <=9.5% at week 2
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
patients must have a fasting plasma glucose (fpg) <=270 mg/dl (15 mmol/l) at week -2
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exposure to JNJ-24831754 | Medical contraindication JNJ-24831754 | Hypersensitivity Suspected JNJ-24831754 | Exposure to Glimepiride | Medical contraindication Glimepiride | Hypersensitivity Suspected Glimepiride | Exposure to Metformin | Medical contraindication Metformin | Hypersensitivity Suspected Metformin
Item
patients having prior exposure or known contraindication or suspected hypersensitivity to jnj-28431754, glimepiride, or metformin
boolean
C0332157 (UMLS CUI [1,1])
C2987596 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2987596 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0061323 (UMLS CUI [3,3])
C0332157 (UMLS CUI [4,1])
C0061323 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0061323 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0061323 (UMLS CUI [6,3])
C0332157 (UMLS CUI [7,1])
C0025598 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0025598 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0750491 (UMLS CUI [9,2])
C0025598 (UMLS CUI [9,3])
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent
Item
history of diabetic ketoacidosis or type 1 diabetes mellitus
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Pancreas Transplantation | Pancreas beta-cell transplantation
Item
history of pancreas or beta-cell transplantation
boolean
C0030275 (UMLS CUI [1])
C0030281 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
Proliferative diabetic retinopathy
Item
history of active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Kidney Disease Requirement Therapeutic immunosuppression | Dialysis | Kidney Transplantation
Item
renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
boolean
C0022658 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
C0011946 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Thiazolidinediones
Item
taken thiazolidinedione therapy in the past 16 weeks before screening
boolean
C1257987 (UMLS CUI [1])
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