ID

31392

Beschrijving

Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00859898

Link

https://clinicaltrials.gov/show/NCT00859898

Trefwoorden

Versies (1)
  1. 19-08-18 19-08-18 -
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see clinicaltrials.gov

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19 augustus 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00859898

Engels

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus
Beschrijving

Therapy naive; Male Gender, Self Report | Age | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C1706180
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0011860
subjects must have central laboratory pre-randomization hemoglobin a1c >= 7.5 and <= 12.0%
Beschrijving

Hemoglobin A1c measurement; Central Laboratory; Randomization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C1880016
UMLS CUI [1,3]
C0034656
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
Beschrijving

Insulin C-peptide measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202100
body mass index <= 45 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
must be able to perform self monitoring of blood glucose
Beschrijving

Blood Glucose Self-Monitoring; Ability

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x*upper limit of normal (uln)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum total bilirubin >2 mg/dl (34.2 µmol/l)
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
creatinine kinase >3*uln
Beschrijving

Creatine kinase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201973
serum creatinine >= 1.50 mg/dl (133 µmol/l) for male subjects, >= 1.40 mg/dl (124
Beschrijving

Creatinine measurement, serum (procedure) | Male Gender, Self Report

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1706180
µmol/l) for female subjects
Beschrijving

Creatinine measurement, serum (procedure); Females

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0086287
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Beschrijving

Cardiovascular Diseases | Kidney Diseases | Liver diseases | Hematological Disease | Neoplasms | Endocrine System Diseases | Mental disorders| Rheumatism

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0205404
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0205404
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C0205404
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [6,3]
C0205404
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [7,3]
C0205404
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [8,3]
C0205404
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive; Male Gender, Self Report | Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus
boolean
C0919936 (UMLS CUI [1,1])
C1706180 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement; Central Laboratory; Randomization
Item
subjects must have central laboratory pre-randomization hemoglobin a1c >= 7.5 and <= 12.0%
boolean
C0474680 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Insulin C-peptide measurement
Item
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index <= 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring; Ability
Item
must be able to perform self monitoring of blood glucose
boolean
C0005803 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x*upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin >2 mg/dl (34.2 µmol/l)
boolean
C1278039 (UMLS CUI [1])
Creatine kinase measurement
Item
creatinine kinase >3*uln
boolean
C0201973 (UMLS CUI [1])
Creatinine measurement, serum (procedure) | Male Gender, Self Report
Item
serum creatinine >= 1.50 mg/dl (133 µmol/l) for male subjects, >= 1.40 mg/dl (124
boolean
C0201976 (UMLS CUI [1])
C1706180 (UMLS CUI [2])
Creatinine measurement, serum (procedure); Females
Item
µmol/l) for female subjects
boolean
C0201976 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
Cardiovascular Diseases | Kidney Diseases | Liver diseases | Hematological Disease | Neoplasms | Endocrine System Diseases | Mental disorders| Rheumatism
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0205404 (UMLS CUI [4,3])
C0027651 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0205404 (UMLS CUI [5,3])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0205404 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0205404 (UMLS CUI [7,3])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0205404 (UMLS CUI [8,3])
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