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ID
30612
Description
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
Keywords
Versions (3)
- 6/14/18 6/14/18 -
- 6/18/18 6/18/18 - Julian Varghese
- 9/27/21 9/27/21 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
June 18, 2018
DOI
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License
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00859898
Eligibility Type 2 Diabetes Mellitus NCT00859898
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00859898
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
C0085732 (UMLS CUI [1,2])
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])
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])
C0086582 (UMLS CUI [1,2])
Creatinine measurement, serum (procedure); female
Item
µmol/l) for female subjects
boolean
C0201976 (UMLS CUI [1,1])
C0015780 (UMLS CUI [1,2])
C0015780 (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])
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])