ID

31392

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 (1)
  1. 8/19/18 8/19/18 -
Copyright Holder

see clinicaltrials.gov

Uploaded on

August 19, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT00859898

English

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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%
Description

Hemoglobin A1c measurement; Central Laboratory; Randomization

Data type

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)
Description

Insulin 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; Ability

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) >3x*upper limit of normal (uln)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
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

Creatine kinase measurement

Data type

boolean

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

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

Data type

boolean

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

Creatinine measurement, serum (procedure); Females

Data type

boolean

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

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

Data type

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
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial