ID

28927

Description

Study Evaluating PPM-204 In Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00425919

Link

https://clinicaltrials.gov/show/NCT00425919

Keywords

Versions (1)
  1. 2/16/18 2/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00425919

English

Eligibility Diabetes Mellitus NCT00425919

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women of non-childbearing potential, 18 to 70 years old
Description

Childbearing Potential Absent | Age

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0001779
subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication
Description

Diet therapy | Remedial exercise | Antidiabetic Oral Single

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0203988
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0205171
bmi > 23 and < 43
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
for subjects currently treated with 1 antidiabetic medication: hba1c is greater than or equal to 6.8% and less than or equal to 8.5%.
Description

Antidiabetics Therapeutic procedure | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0202054
for subjects not currently treated with antidiabetic medications: hba1c is greater than or equal to 7.2% and less than or equal to 9.0%
Description

Antidiabetics Therapeutic procedure Absent | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0202054
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects requiring insulin therapy
Description

Patient need for Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0557978
subjects currently receiving 2 or more oral antidiabetic medications
Description

Antidiabetics Oral Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
Description

Patient need for CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Procedure discontinued (treatment)

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3653708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0520253
subjects receiving warfarin
Description

Warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
Description

Thiazolidinediones | Exception Procedure discontinued (treatment)

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0520253
significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)
Description

Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | Neuropathy Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C0442874
UMLS CUI [4,2]
C0231220
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Similar models

Eligibility Diabetes Mellitus NCT00425919

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Absent | Age
Item
men and women of non-childbearing potential, 18 to 70 years old
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Diet therapy | Remedial exercise | Antidiabetic Oral Single
Item
subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication
boolean
C0012159 (UMLS CUI [1])
C0203988 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
Body mass index
Item
bmi > 23 and < 43
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Therapeutic procedure | Glucohemoglobin measurement
Item
for subjects currently treated with 1 antidiabetic medication: hba1c is greater than or equal to 6.8% and less than or equal to 8.5%.
boolean
C0935929 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
Antidiabetics Therapeutic procedure Absent | Glucohemoglobin measurement
Item
for subjects not currently treated with antidiabetic medications: hba1c is greater than or equal to 7.2% and less than or equal to 9.0%
boolean
C0935929 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0202054 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patient need for Insulin regime
Item
subjects requiring insulin therapy
boolean
C0686904 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Antidiabetics Oral Quantity
Item
subjects currently receiving 2 or more oral antidiabetic medications
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Patient need for CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Procedure discontinued (treatment)
Item
subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
boolean
C0686904 (UMLS CUI [1,1])
C3653708 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0520253 (UMLS CUI [2,2])
Warfarin
Item
subjects receiving warfarin
boolean
C0043031 (UMLS CUI [1])
Thiazolidinediones | Exception Procedure discontinued (treatment)
Item
subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
boolean
C1257987 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0520253 (UMLS CUI [2,2])
Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | Neuropathy Symptomatic
Item
significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)
boolean
C0342257 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0442874 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
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