ID

17220

Description

A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00263276

Link

https://clinicaltrials.gov/show/NCT00263276

Keywords

  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00263276

Eligibility Type 2 Diabetes NCT00263276

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. hba1c >= 7% and <=10%.
Description

type 2 diabetes mellitus with inadequate glycemic control on diet and exercise; HbA1c

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0421246
UMLS CUI [3]
C0202054
patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
Description

hypoglycemic agents

Data type

boolean

Alias
UMLS CUI [1]
C0020616
c-peptide > 1.0 ng/ml
Description

c-peptide

Data type

boolean

Alias
UMLS CUI [1]
C0202100
body mass index <= 40 kg/m2
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
serum creatinine < 1.5 mg/dl for men or < 1.4 mg/dl for women.
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
no overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g
Description

microalbumin/creatinine ratio

Data type

boolean

Alias
UMLS CUI [1]
C0486293
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable renal disease
Description

renal disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
patients with significant liver disease including chronic active hepatitis
Description

liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable chf,nyha class iii or iv chf, tia, unstable arrhythmia or cardiac revascularization surgery.
Description

myocardial infarction, unstable angina, unstable chf,nyha class iii or iv chf, tia, unstable arrhythmia or cardiac revascularization surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C1275491
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0003811
UMLS CUI [7]
C0027056
subjects with clinically significant anemia
Description

anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871

Similar models

Eligibility Type 2 Diabetes NCT00263276

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetes mellitus with inadequate glycemic control on diet and exercise; HbA1c
Item
patients with type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. hba1c >= 7% and <=10%.
boolean
C0011860 (UMLS CUI [1])
C0421246 (UMLS CUI [2])
C0202054 (UMLS CUI [3])
hypoglycemic agents
Item
patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
boolean
C0020616 (UMLS CUI [1])
c-peptide
Item
c-peptide > 1.0 ng/ml
boolean
C0202100 (UMLS CUI [1])
BMI
Item
body mass index <= 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
serum creatinine
Item
serum creatinine < 1.5 mg/dl for men or < 1.4 mg/dl for women.
boolean
C0201976 (UMLS CUI [1])
microalbumin/creatinine ratio
Item
no overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g
boolean
C0486293 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
renal disease
Item
unstable renal disease
boolean
C0022658 (UMLS CUI [1])
liver disease
Item
patients with significant liver disease including chronic active hepatitis
boolean
C0023895 (UMLS CUI [1])
myocardial infarction, unstable angina, unstable chf,nyha class iii or iv chf, tia, unstable arrhythmia or cardiac revascularization surgery
Item
within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable chf,nyha class iii or iv chf, tia, unstable arrhythmia or cardiac revascularization surgery.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0027056 (UMLS CUI [7])
anemia
Item
subjects with clinically significant anemia
boolean
C0002871 (UMLS CUI [1])

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