ID

34597

Description

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise; ODM derived from: https://clinicaltrials.gov/show/NCT01095653

Link

https://clinicaltrials.gov/show/NCT01095653

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT01095653

Eligibility Type 2 Diabetes NCT01095653

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
Description

ID.1

Data type

boolean

drug naive or treated with anti-diabetic medication for < 24 weeks
Description

ID.2

Data type

boolean

c-peptide ≥ 1.0 ng/ml
Description

ID.3

Data type

boolean

body mass index ≤ 45.0 kg/m²
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ast and/or alt > 3 times uln
Description

ID.5

Data type

boolean

serum total bilirubin > 2 mg/dl
Description

ID.6

Data type

boolean

serum creatinine ≥ 1.50 mg/dl for men or ≥ 1.40 mg/dl for women
Description

ID.7

Data type

boolean

creatine kinase ≥ 3 times uln
Description

ID.8

Data type

boolean

symptoms of severely uncontrolled diabetes
Description

ID.9

Data type

boolean

currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Description

ID.10

Data type

boolean

Similar models

Eligibility Type 2 Diabetes NCT01095653

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
boolean
ID.2
Item
drug naive or treated with anti-diabetic medication for < 24 weeks
boolean
ID.3
Item
c-peptide ≥ 1.0 ng/ml
boolean
ID.4
Item
body mass index ≤ 45.0 kg/m²
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
ast and/or alt > 3 times uln
boolean
ID.6
Item
serum total bilirubin > 2 mg/dl
boolean
ID.7
Item
serum creatinine ≥ 1.50 mg/dl for men or ≥ 1.40 mg/dl for women
boolean
ID.8
Item
creatine kinase ≥ 3 times uln
boolean
ID.9
Item
symptoms of severely uncontrolled diabetes
boolean
ID.10
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean

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