ID

29009

Description

Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01029704

Link

https://clinicaltrials.gov/show/NCT01029704

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT01029704

English

Eligibility Diabetes Mellitus Type 2 NCT01029704

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
body mass index (bmi) between 18 kg/m2 and 37 kg/m2 (inclusive).
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the hba1c assay is 6.4% or hba1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the hba1c assay is 6.1%.
Description

Glucohemoglobin measurement | Relationship Upper Limit of Normal

Data type

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C1519815
fasting plasma glucose levels between 126 and 270 mg/dl (7 - 15 mmol/l, inclusive) while on diabetic medications.
Description

Plasma fasting glucose measurement | Intake Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0935929
treatment naïve subjects with hba1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dl (7 - 15 mmol/l).
Description

Study Subject Therapy naive | Glucohemoglobin measurement | Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0202054
UMLS CUI [3]
C0583513
if taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
Description

Antidiabetics Discontinue Able | Antidiabetics Discontinue Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0600109
female subjects must be surgically sterilized or postmenopausal.
Description

Gender | Female Sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes or diabetes treated with insulin injection.
Description

Diabetes Mellitus, Insulin-Dependent | Injection of insulin Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0011849
insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
Description

Insulin regime | Antidiabetics Oral | Exception Metformin | Exception sitagliptin | Exception saxagliptin | Exception Sulfonylurea | Exception Combination Pharmaceutical Preparations Specified

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1565750
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1611934
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0038766
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0205195
UMLS CUI [7,3]
C0013227
UMLS CUI [7,4]
C0205369
sitting blood pressure above 150/95 mmhg on two evaluations at least 10 minutes apart at screening.
Description

Sitting blood pressure | Evaluation Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0580946
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C1265611
positive results on screen for drugs of abuse.
Description

Drug screen positive | Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2]
C0013146
previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
previous treatment with egt0001474 or egt0001442.
Description

Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C3846158
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT01029704

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) between 18 kg/m2 and 37 kg/m2 (inclusive).
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement | Relationship Upper Limit of Normal
Item
hba1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the hba1c assay is 6.4% or hba1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the hba1c assay is 6.1%.
boolean
C0202054 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1519815 (UMLS CUI [2,2])
Plasma fasting glucose measurement | Intake Antidiabetics
Item
fasting plasma glucose levels between 126 and 270 mg/dl (7 - 15 mmol/l, inclusive) while on diabetic medications.
boolean
C0583513 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
Study Subject Therapy naive | Glucohemoglobin measurement | Plasma fasting glucose measurement
Item
treatment naïve subjects with hba1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dl (7 - 15 mmol/l).
boolean
C0681850 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
Antidiabetics Discontinue Able | Antidiabetics Discontinue Willing
Item
if taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
boolean
C0935929 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Gender | Female Sterilization | Postmenopausal state
Item
female subjects must be surgically sterilized or postmenopausal.
boolean
C0079399 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Injection of insulin Diabetes Mellitus
Item
type 1 diabetes or diabetes treated with insulin injection.
boolean
C0011854 (UMLS CUI [1])
C0199782 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Insulin regime | Antidiabetics Oral | Exception Metformin | Exception sitagliptin | Exception saxagliptin | Exception Sulfonylurea | Exception Combination Pharmaceutical Preparations Specified
Item
insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
boolean
C0557978 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1565750 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1611934 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0038766 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0205195 (UMLS CUI [7,2])
C0013227 (UMLS CUI [7,3])
C0205369 (UMLS CUI [7,4])
Sitting blood pressure | Evaluation Quantity
Item
sitting blood pressure above 150/95 mmhg on two evaluations at least 10 minutes apart at screening.
boolean
C0580946 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Drug screen positive | Drug abuse
Item
positive results on screen for drugs of abuse.
boolean
C0743295 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Investigational New Drugs
Item
previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
boolean
C0013230 (UMLS CUI [1])
Other Coding
Item
previous treatment with egt0001474 or egt0001442.
boolean
C3846158 (UMLS CUI [1])
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