ID

32929

Description

Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012); ODM derived from: https://clinicaltrials.gov/show/NCT00972322

Link

https://clinicaltrials.gov/show/NCT00972322

Keywords

Versions (1)
  1. 11/20/18 11/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 20, 2018

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 NCT00972322

English

Eligibility Type 2 Diabetes Mellitus NCT00972322

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Oral hypoglycemic Single | Combination Oral hypoglycemic Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C0205171
UMLS CUI [5,1]
C0205195
UMLS CUI [5,2]
C0359086
UMLS CUI [5,3]
C1265611
subject is willing to follow a weight-maintaining diet and exercise program during the study
Description

Adherence Weight maintenance diet | Adherence Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0311129
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0015259
subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit
Description

Non-smoker | Restrict smoking Number of cigarettes per day Willing

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0515592
UMLS CUI [2,2]
C3694146
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of stroke, chronic seizures, or major neurological disorder
Description

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
Description

Malignant Neoplasms | Exception Skin carcinoma Some | Exception Cervix carcinoma Some | Exception Malignant Neoplasms Treated Successful

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C0205392
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [3,3]
C0205392
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1522326
UMLS CUI [4,4]
C1272703
subject has a history of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
subject has used contact lenses within the last 6 months
Description

Use of Contact Lenses

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0009836
subject has used any lipid-lowering therapy in the last 3 months, except statins, zetia, or vytorin
Description

Lipid-lowering therapy | Exception Statins | Exception Zetia | Exception Vytorin

Data type

boolean

Alias
UMLS CUI [1]
C0585943
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0360714
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1170736
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1527845
subject has more than 3 alcoholic beverages per day
Description

Alcoholic Beverages U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001967
UMLS CUI [1,2]
C0456683
subject has more than 6 servings of caffeine a day
Description

Caffeine Serving U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0006644
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0456683
subject has participated in a previous mk8245 study
Description

Study Subject Participation Status | MK-8245

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3252063
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00972322

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Oral hypoglycemic Single | Combination Oral hypoglycemic Quantity
Item
subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0359086 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0205195 (UMLS CUI [5,1])
C0359086 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Adherence Weight maintenance diet | Adherence Exercise
Item
subject is willing to follow a weight-maintaining diet and exercise program during the study
boolean
C1510802 (UMLS CUI [1,1])
C0311129 (UMLS CUI [1,2])
C1510802 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
Non-smoker | Restrict smoking Number of cigarettes per day Willing
Item
subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit
boolean
C0337672 (UMLS CUI [1])
C0515592 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
subject has a history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Skin carcinoma Some | Exception Cervix carcinoma Some | Exception Malignant Neoplasms Treated Successful
Item
subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0205392 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C0205392 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1272703 (UMLS CUI [4,4])
Diabetes Mellitus, Insulin-Dependent
Item
subject has a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Use of Contact Lenses
Item
subject has used contact lenses within the last 6 months
boolean
C1524063 (UMLS CUI [1,1])
C0009836 (UMLS CUI [1,2])
Lipid-lowering therapy | Exception Statins | Exception Zetia | Exception Vytorin
Item
subject has used any lipid-lowering therapy in the last 3 months, except statins, zetia, or vytorin
boolean
C0585943 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0360714 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1170736 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1527845 (UMLS CUI [4,2])
Alcoholic Beverages U/day
Item
subject has more than 3 alcoholic beverages per day
boolean
C0001967 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Caffeine Serving U/day
Item
subject has more than 6 servings of caffeine a day
boolean
C0006644 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Study Subject Participation Status | MK-8245
Item
subject has participated in a previous mk8245 study
boolean
C2348568 (UMLS CUI [1])
C3252063 (UMLS CUI [2])
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