ID

20543

Description

A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00672386

Link

https://clinicaltrials.gov/show/NCT00672386

Keywords

Versions (1)
  1. 3/2/17 3/2/17 -
Uploaded on

March 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00672386

English

Eligibility Diabetes Mellitus, Type 2 NCT00672386

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
history of type 2 diabetes mellitus and treated with a stable dose of metformin for at least 2 months
Description

type 2 diabetes mellitus, metformin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
Description

Gender | Postmenopausal state | Childbearing Potential | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0700589
bmi between 25 and 45 kg/m2
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7% and 10%, inclusive
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
fasting plasma glucose not exceeding 240mg/dl (13.3mmol/l)
Description

fasting plasma glucose

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes other than type 2 diabetes mellitus
Description

diabetes type

Data type

boolean

Alias
UMLS CUI [1]
C1320657
treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
Description

oral hypoglycemic, insulin

Data type

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0021641
history of intolerance or hypersensitivity to sulfonylurea or sitagliptin
Description

intolerance or hypersensitivity to sulfonylurea or sitagliptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038766
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1565750
history of clinically significant gastrointestinal, hepatic or cardiovascular disease
Description

history of clinically significant gastrointestinal, hepatic or cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0007222
active proliferative diabetic retinopathy
Description

active proliferative diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0205177
history of diabetic gastroparesis
Description

diabetic gastroparesis

Data type

boolean

Alias
UMLS CUI [1]
C0267176
concurrent use of systemic corticosteroid
Description

steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0149783
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00672386

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 2 diabetes mellitus, metformin
Item
history of type 2 diabetes mellitus and treated with a stable dose of metformin for at least 2 months
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Gender | Postmenopausal state | Childbearing Potential | Contraceptive methods
Item
women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
bmi
Item
bmi between 25 and 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
hba1c
Item
hba1c between 7% and 10%, inclusive
boolean
C0019018 (UMLS CUI [1])
fasting plasma glucose
Item
fasting plasma glucose not exceeding 240mg/dl (13.3mmol/l)
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
diabetes type
Item
diabetes other than type 2 diabetes mellitus
boolean
C1320657 (UMLS CUI [1])
oral hypoglycemic, insulin
Item
treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
intolerance or hypersensitivity to sulfonylurea or sitagliptin
Item
history of intolerance or hypersensitivity to sulfonylurea or sitagliptin
boolean
C0020517 (UMLS CUI [1,1])
C0038766 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1565750 (UMLS CUI [2,2])
history of clinically significant gastrointestinal, hepatic or cardiovascular disease
Item
history of clinically significant gastrointestinal, hepatic or cardiovascular disease
boolean
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
active proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
diabetic gastroparesis
Item
history of diabetic gastroparesis
boolean
C0267176 (UMLS CUI [1])
steroid therapy
Item
concurrent use of systemic corticosteroid
boolean
C0149783 (UMLS CUI [1])
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