ID

21097

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00290940

Nyckelord

  1. 2017-04-10 2017-04-10 -
Uppladdad den

10 april 2017

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00290940

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Diabetes mellitus type 2: newly diagnosed

Datatyp

boolean

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

Never received diabetes mellitus therapy

Datatyp

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
Beskrivning

Diabetes mellitus therapy: last half year

Datatyp

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
Beskrivning

Insulin therapy

Datatyp

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.
Beskrivning

Antihyperglycemic therapy

Datatyp

boolean

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

HbA1c

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current insulin therapy
Beskrivning

Current insulin therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
poorly controlled diabetes
Beskrivning

Diabetes mellitus poor control

Datatyp

boolean

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

Diabetic ketoacidosis or hyperosmolar, nonketonic coma

Datatyp

boolean

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

Serum bicarbonate measurement

Datatyp

boolean

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

Serum creatinine measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
contraindication to metformin
Beskrivning

Contraindication to metformin

Datatyp

boolean

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

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00290940

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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