ID

37317

Description

Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02081599

Link

https://clinicaltrials.gov/show/NCT02081599

Keywords

Versions (1)
  1. 7/16/19 7/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 16, 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.

Back to model comments
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 NCT02081599

English

Eligibility Type 2 Diabetes Mellitus NCT02081599

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
Description

Insulin Dose Stable | Insulin regime Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0205360
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Description

Diet therapy | Therapeutic exercise Duration Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C1455811
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0011849
patients whose hba1c is between 7.5% and 10.5%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Description

Absence Antidiabetics Illicit

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C0332266
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreas Impairment | Secondary diabetes mellitus | Cushing's disease | Acromegaly

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0030274
UMLS CUI [2,4]
C0221099
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0221406
UMLS CUI [5]
C0001206
patients who are accepting treatments of arrhythmias
Description

Treatment Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003811
patients with serious diabetic complications
Description

Complications of Diabetes Mellitus Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205404
patients who are the excessive alcohol addicts
Description

Alcohol addiction Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0442802
patients with severe hepatic disorder or severe renal disorder.
Description

Liver disease Severe | Kidney Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Description

Pregnancy | Breast Feeding | Pregnancy Probably | Patients Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02081599

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin Dose Stable | Insulin regime Stable
Item
patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0557978 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Diet therapy | Therapeutic exercise Duration Diabetes Mellitus
Item
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
boolean
C0012159 (UMLS CUI [1])
C1455811 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
patients whose hba1c is between 7.5% and 10.5%
boolean
C0474680 (UMLS CUI [1])
Absence Antidiabetics Illicit
Item
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
boolean
C0332197 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreas Impairment | Secondary diabetes mellitus | Cushing's disease | Acromegaly
Item
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0030274 (UMLS CUI [2,3])
C0221099 (UMLS CUI [2,4])
C0271640 (UMLS CUI [3])
C0221406 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
Treatment Cardiac Arrhythmia
Item
patients who are accepting treatments of arrhythmias
boolean
C0087111 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Serious
Item
patients with serious diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Alcohol addiction Excessive
Item
patients who are the excessive alcohol addicts
boolean
C0001973 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
Liver disease Severe | Kidney Disease Severe
Item
patients with severe hepatic disorder or severe renal disorder.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy Probably | Patients Contraceptive methods Unwilling
Item
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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