ID

44557

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 (3)
  1. 14-06-18 14-06-18 -
  2. 18-06-18 18-06-18 - Julian Varghese
  3. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2021

DOI

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Licentie

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

Diabetes Mellitus; Type 2; Therapy naive; Age

Datatype

boolean

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

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
Beschrijving

C-Peptide

Datatype

boolean

Alias
UMLS CUI [1]
C0006558
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 increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
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); Males

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0086582
µmol/l) for female subjects
Beschrijving

Creatinine measurement, serum (procedure); female

Datatype

boolean

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

Cardiovascular system; Function | Renal function | Liver function | Hematological Disease | Disease; Oncologic | Endocrine System Diseases | Mental disorders | Rheumatism

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0542341
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0018939
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205478
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0035435
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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)
Diabetes Mellitus; Type 2; Therapy naive; Age
Item
treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Glycosylated hemoglobin A
Item
subjects must have central laboratory pre-randomization hemoglobin a1c >= 7.5 and <= 12.0%
boolean
C0019018 (UMLS CUI [1])
C-Peptide
Item
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
boolean
C0006558 (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 increased | Alanine aminotransferase increased
Item
aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x*upper limit of normal (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (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); Males
Item
serum creatinine >= 1.50 mg/dl (133 µmol/l) for male subjects, >= 1.40 mg/dl (124
boolean
C0201976 (UMLS CUI [1,1])
C0086582 (UMLS CUI [1,2])
Creatinine measurement, serum (procedure); female
Item
µmol/l) for female subjects
boolean
C0201976 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
Cardiovascular system; Function | Renal function | Liver function | Hematological Disease | Disease; Oncologic | Endocrine System Diseases | Mental disorders | Rheumatism
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean
C0007226 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205478 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0035435 (UMLS CUI [8])
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