ID

21097

Description

Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917; ODM derived from: https://clinicaltrials.gov/show/NCT00290940

Link

https://clinicaltrials.gov/show/NCT00290940

Keywords

  1. 4/10/17 4/10/17 -
Uploaded on

April 10, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00290940

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
drug naive or newly diagnosed type 2 diabetic subjects:
Description

Diabetes mellitus type 2: newly diagnosed

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1518321
never received oral antihyperglycemic or insulin therapy or
Description

Never received diabetes mellitus therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C2003901
no oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
Description

Diabetes mellitus therapy: last half year

Data type

boolean

Alias
UMLS CUI [1,1]
C0948092
UMLS CUI [1,2]
C4082120
no insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
Description

Insulin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0557978
no antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
Description

Antihyperglycemic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0020616
hba1c>6.7% and < or = to 10% at screening
Description

HbA1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current insulin therapy
Description

Current insulin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0557978
poorly controlled diabetes
Description

Diabetes mellitus poor control

Data type

boolean

Alias
UMLS CUI [1]
C0860161
history of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
Description

Diabetic ketoacidosis or hyperosmolar, nonketonic coma

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0020457
serum bicarbonate < or = to 19 meq/l
Description

Serum bicarbonate measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428301
serum creatinine (scr) > 1.4 mg/dl (females) or 1.5 mg/dl (males)
Description

Serum creatinine measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
contraindication to metformin
Description

Contraindication to metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1301624

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes mellitus type 2: newly diagnosed
Item
drug naive or newly diagnosed type 2 diabetic subjects:
boolean
C0011860 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
Never received diabetes mellitus therapy
Item
never received oral antihyperglycemic or insulin therapy or
boolean
C0948092 (UMLS CUI [1,1])
C2003901 (UMLS CUI [1,2])
Diabetes mellitus therapy: last half year
Item
no oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
boolean
C0948092 (UMLS CUI [1,1])
C4082120 (UMLS CUI [1,2])
Insulin therapy
Item
no insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
boolean
C0557978 (UMLS CUI [1])
Antihyperglycemic therapy
Item
no antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
boolean
C0020616 (UMLS CUI [1])
HbA1c
Item
hba1c>6.7% and < or = to 10% at screening
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Current insulin therapy
Item
current insulin therapy
boolean
C0557978 (UMLS CUI [1])
Diabetes mellitus poor control
Item
poorly controlled diabetes
boolean
C0860161 (UMLS CUI [1])
Diabetic ketoacidosis or hyperosmolar, nonketonic coma
Item
history of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
boolean
C0011880 (UMLS CUI [1])
C0020457 (UMLS CUI [2])
Serum bicarbonate measurement
Item
serum bicarbonate < or = to 19 meq/l
boolean
C0428301 (UMLS CUI [1])
Serum creatinine measurement
Item
serum creatinine (scr) > 1.4 mg/dl (females) or 1.5 mg/dl (males)
boolean
C0201976 (UMLS CUI [1])
Contraindication to metformin
Item
contraindication to metformin
boolean
C0025598 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])

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