ID

34715

Description

Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01387737

Link

https://clinicaltrials.gov/show/NCT01387737

Keywords

  1. 1/24/19 1/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 24, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT01387737

Eligibility Type 2 Diabetes Mellitus NCT01387737

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women age ≥20 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus at least 3 months before screening
Description

Non-Insulin-Dependent Diabetes Mellitus Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
hba1c of ≥7.0% and ≤10.0% (monotherapy group)
Description

Hemoglobin A1c measurement | Group Therapy Singular

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205171
hba1c of ≥7.0% and ≤10.5% (combination therapy group)
Description

Hemoglobin A1c measurement | Group Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C0009429
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0030286
UMLS CUI [3]
C0271640
past or current history of severe diabetic complications
Description

Complications of Diabetes Mellitus Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205082
fasting plasma glucose > 270 mg/dl before treatment start
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
Description

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Data type

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
patients requiring insulin therapy
Description

Patient need for Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0557978

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01387737

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women age ≥20 years old
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
diagnosed with type 2 diabetes mellitus at least 3 months before screening
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Group Therapy Singular
Item
hba1c of ≥7.0% and ≤10.0% (monotherapy group)
boolean
C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
Hemoglobin A1c measurement | Group Combined Modality Therapy
Item
hba1c of ≥7.0% and ≤10.5% (combination therapy group)
boolean
C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C0009429 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Due to Pancreatic Diseases | Secondary diabetes mellitus
Item
type i diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0030286 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
Complications of Diabetes Mellitus Severe
Item
past or current history of severe diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose > 270 mg/dl before treatment start
boolean
C0583513 (UMLS CUI [1])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Patient need for Insulin regime
Item
patients requiring insulin therapy
boolean
C0686904 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial