ID

29191

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00968812

Nyckelord

Versioner (1)
  1. 2018-03-05 2018-03-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 mars 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes Mellitus, Type 2 NCT00968812

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00968812

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

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

Body mass index

Datatyp

boolean

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

Metformin Dosage Stable

Datatyp

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
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

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

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

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

Pancreas Transplantation | Pancreas beta-cell transplantation

Datatyp

boolean

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

Proliferative diabetic retinopathy

Datatyp

boolean

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

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Datatyp

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
Beskrivning

Kidney Disease Requirement Therapeutic immunosuppression | Dialysis | Kidney Transplantation

Datatyp

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
Beskrivning

Thiazolidinediones

Datatyp

boolean

Alias
UMLS CUI [1]
C1257987
Tillbaka till toppen

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00968812

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial