ID

24028

Description

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00528879

Link

https://clinicaltrials.gov/show/NCT00528879

Keywords

  1. 7/23/17 7/23/17 -
  2. 7/23/17 7/23/17 -
Uploaded on

July 23, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00528879

Eligibility Type 2 Diabetes NCT00528879

Criteria
Description

Criteria

males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0011860
participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0025598
c-peptide ≥1.0 ng/ml
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0202100
body mass index ≤45.0 kg/m^2
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C1305855
serum creatinine level <1.50 mg/dl for men or <1.40 mg/dl for women.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0600061
key exclusion criteria
Description

key exclusion criteria

aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0004002
UMLS CUI [1,2]
C0001899
serum total bilirubin level >2 mg/dl
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C1278039
creatinine kinase level >3 times upper limit of normal
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C1657311
symptoms of severely uncontrolled diabetes
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0810250
serum creatinine level 1.50 mg/dl for men or 1.40 mg/dl for women
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0600061
currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0012634

Similar models

Eligibility Type 2 Diabetes NCT00528879

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ID.1
Item
males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
boolean
C0001779 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
ID.2
Item
participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
boolean
C0025598 (UMLS CUI [1])
ID.3
Item
c-peptide ≥1.0 ng/ml
boolean
C0202100 (UMLS CUI [1])
ID.4
Item
body mass index ≤45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
ID.5
Item
serum creatinine level <1.50 mg/dl for men or <1.40 mg/dl for women.
boolean
C0600061 (UMLS CUI [1])
Item Group
key exclusion criteria
ID.7
Item
aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
boolean
C0004002 (UMLS CUI [1,1])
C0001899 (UMLS CUI [1,2])
ID.8
Item
serum total bilirubin level >2 mg/dl
boolean
C1278039 (UMLS CUI [1])
ID.9
Item
creatinine kinase level >3 times upper limit of normal
boolean
C1657311 (UMLS CUI [1])
ID.10
Item
symptoms of severely uncontrolled diabetes
boolean
C0810250 (UMLS CUI [1])
ID.11
Item
serum creatinine level 1.50 mg/dl for men or 1.40 mg/dl for women
boolean
C0600061 (UMLS CUI [1])
ID.12
Item
currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
boolean
C0443343 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])

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