ID

21097

Beschrijving

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

Trefwoorden

  1. 10-04-17 10-04-17 -
Geüploaded op

10 april 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00290940

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Diabetes mellitus type 2: newly diagnosed

Datatype

boolean

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

Never received diabetes mellitus therapy

Datatype

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
Beschrijving

Diabetes mellitus therapy: last half year

Datatype

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
Beschrijving

Insulin therapy

Datatype

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.
Beschrijving

Antihyperglycemic therapy

Datatype

boolean

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

HbA1c

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
current insulin therapy
Beschrijving

Current insulin therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
poorly controlled diabetes
Beschrijving

Diabetes mellitus poor control

Datatype

boolean

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

Diabetic ketoacidosis or hyperosmolar, nonketonic coma

Datatype

boolean

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

Serum bicarbonate measurement

Datatype

boolean

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

Serum creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
contraindication to metformin
Beschrijving

Contraindication to metformin

Datatype

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)
Datatype
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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