ID

29203

Description

An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00642278

Link

https://clinicaltrials.gov/show/NCT00642278

Keywords

Versions (1)
  1. 3/7/18 3/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT00642278

English

Eligibility Diabetes Mellitus, Type II NCT00642278

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hemoglobin a1c levels >=7% and <=10.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
taking a stable daily dose of metformin
Description

Metformin Dose Stable per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0439505
body mass index (bmi) 25 to 45 kg/m2 except those of asian descent who must have a bmi of 24 to 45 kg/m2
Description

Body mass index | Asians

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0078988
stable body weight
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
serum creatinine <=1.5 mg/dl (132.6 umol/l) for men and <=1.4 mg/dl (123.76 umol/l) for women
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (jnj-28431754)
Description

Exposure to canagliflozin | Medical contraindication canagliflozin | Hypersensitivity Suspected canagliflozin | Exposure to JNJ-28431754 | Medical contraindication JNJ-28431754 | Hypersensitivity Suspected JNJ-28431754

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2974540
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C2974540
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C2974540
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C2987596
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C2987596
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C2987596
known contraindication or suspected hypersensitivity to sitagliptin or metformin
Description

Medical contraindication sitagliptin | Medical contraindication Metformin | Hypersensitivity Suspected sitagliptin | Hypersensitivity Suspected Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1565750
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C1565750
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0025598
a history of diabetic ketoacidosis or type 1 diabetes mellitus
Description

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent

Data type

boolean

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

Pancreas Transplantation | Pancreatic beta cell Transplantation

Data type

boolean

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

Proliferative diabetic retinopathy

Data type

boolean

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

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Data type

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
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Similar models

Eligibility Diabetes Mellitus, Type II NCT00642278

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients must have a diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hemoglobin a1c levels >=7% and <=10.5%
boolean
C0202054 (UMLS CUI [1])
Metformin Dose Stable per day
Item
taking a stable daily dose of metformin
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Body mass index | Asians
Item
body mass index (bmi) 25 to 45 kg/m2 except those of asian descent who must have a bmi of 24 to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
Stable body weight
Item
stable body weight
boolean
C0517386 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine <=1.5 mg/dl (132.6 umol/l) for men and <=1.4 mg/dl (123.76 umol/l) for women
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exposure to canagliflozin | Medical contraindication canagliflozin | Hypersensitivity Suspected canagliflozin | Exposure to JNJ-28431754 | Medical contraindication JNJ-28431754 | Hypersensitivity Suspected JNJ-28431754
Item
patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (jnj-28431754)
boolean
C0332157 (UMLS CUI [1,1])
C2974540 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2974540 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C2974540 (UMLS CUI [3,3])
C0332157 (UMLS CUI [4,1])
C2987596 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C2987596 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C2987596 (UMLS CUI [6,3])
Medical contraindication sitagliptin | Medical contraindication Metformin | Hypersensitivity Suspected sitagliptin | Hypersensitivity Suspected Metformin
Item
known contraindication or suspected hypersensitivity to sitagliptin or metformin
boolean
C1301624 (UMLS CUI [1,1])
C1565750 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C1565750 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0025598 (UMLS CUI [4,3])
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent
Item
a history of diabetic ketoacidosis or type 1 diabetes mellitus
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Pancreas Transplantation | Pancreatic 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])
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