ID

32929

Beschrijving

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

Trefwoorden

Versies (1)
  1. 20-11-18 20-11-18 -
Houder van rechten

See clinicaltrials.gov

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20 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00972322

Engels

Eligibility Type 2 Diabetes Mellitus NCT00972322

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

Adherence Weight maintenance diet | Adherence Exercise

Datatype

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
Beschrijving

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

Datatype

boolean

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

Exclusion Criteria

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

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

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

Use of Contact Lenses

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Alcoholic Beverages U/day

Datatype

boolean

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

Caffeine Serving U/day

Datatype

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
Beschrijving

Study Subject Participation Status | MK-8245

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3252063
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00972322

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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