ID

32795

Description

Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00736879

Link

https://clinicaltrials.gov/show/NCT00736879

Keywords

Versions (1)
  1. 11/15/18 11/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00736879

English

Eligibility Type 2 Diabetes Mellitus NCT00736879

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
subjects must have central laboratory pre-randomization a1c ≥7.0 and ≤ 10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
c-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
body mass index ≤ 45 kg/m²
Description

Body mass index

Data type

boolean

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

Blood Glucose Self-Monitoring Able

Data type

boolean

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

Exclusion Criteria

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum total bilirubin >2 mg/dl (34.2 µmol/l)
Description

Serum total bilirubin measurement

Data type

boolean

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

Elevated creatinine kinase

Data type

boolean

Alias
UMLS CUI [1]
C1657311
serum creatinine ≥1.50 mg/dl (133 µmol/l) for male subjects, ≥1.40 mg/dl (124 µmol/l) for female subjects
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Description

Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0442867
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0007222
UMLS CUI [9,2]
C0205404
UMLS CUI [10,1]
C0022658
UMLS CUI [10,2]
C0205404
UMLS CUI [11,1]
C0023895
UMLS CUI [11,2]
C0205404
UMLS CUI [12,1]
C0018939
UMLS CUI [12,2]
C0205404
UMLS CUI [13,1]
C0442867
UMLS CUI [13,2]
C0205404
UMLS CUI [14,1]
C0014130
UMLS CUI [14,2]
C0205404
UMLS CUI [15,1]
C0004936
UMLS CUI [15,2]
C0205404
UMLS CUI [16,1]
C0035435
UMLS CUI [16,2]
C0205404
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00736879

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
subjects must have central laboratory pre-randomization a1c ≥7.0 and ≤ 10.0%
boolean
C0474680 (UMLS CUI [1])
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 Able
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) >3* 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])
Elevated creatinine kinase
Item
creatinine kinase >3* uln
boolean
C1657311 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine ≥1.50 mg/dl (133 µmol/l) for male subjects, ≥1.40 mg/dl (124 µmol/l) for female subjects
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Cardiovascular Diseases Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Malignant disease Unstable | Endocrine System Diseases Unstable | Mental disorders Unstable | Rheumatism Unstable | Cardiovascular Diseases Serious | Kidney Diseases Serious | Liver diseases Serious | Hematological Disease Serious | Malignant disease Serious | Endocrine System Diseases Serious | Mental disorders Serious | Rheumatism Serious
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])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0442867 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0007222 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0022658 (UMLS CUI [10,1])
C0205404 (UMLS CUI [10,2])
C0023895 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C0018939 (UMLS CUI [12,1])
C0205404 (UMLS CUI [12,2])
C0442867 (UMLS CUI [13,1])
C0205404 (UMLS CUI [13,2])
C0014130 (UMLS CUI [14,1])
C0205404 (UMLS CUI [14,2])
C0004936 (UMLS CUI [15,1])
C0205404 (UMLS CUI [15,2])
C0035435 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
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