ID

32861

Beskrivning

A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110); ODM derived from: https://clinicaltrials.gov/show/NCT00830076

Länk

https://clinicaltrials.gov/show/NCT00830076

Nyckelord

Versioner (1)
  1. 2018-11-17 2018-11-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00830076

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00830076

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female subjects must have a negative pregnancy test
Beskrivning

Gender Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
subject has type 2 diabetes and is not currently receiving treatment with an oral aha agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral aha agent for 12 to 18 months prior to the study
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0332197
subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
Beskrivning

Non-smoker | Tobacco use Absent Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0449238
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of stroke, seizures, or major neurological disorders
Beskrivning

Cerebrovascular accident | Seizures | Nervous system disorder Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0036572
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
female subject is breastfeeding
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
Beskrivning

Pharmaceutical Preparations Unable to discontinue | Non-Prescription Drugs Unable to discontinue

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1548265
subject consumes more than 3 alcoholic beverages per day
Beskrivning

Consumption Alcoholic Beverages U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
subject consumes more than 6 caffeinated beverages per day
Beskrivning

Consumption Caffeinated beverage U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948365
UMLS CUI [1,2]
C0678438
UMLS CUI [1,3]
C0456683
subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
Beskrivning

Major surgery | Blood Donation Unit Quantity | Blood Loss Unit Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C0439148
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C0439148
UMLS CUI [3,3]
C1265611
subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
Beskrivning

Malignant Neoplasms | Exception Skin carcinoma | Exception Cervix carcinoma Specified | Exception Cancer Other Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [3,3]
C0205369
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C1522326
subject has a history of multiple and/or severe allergies or intolerance to drugs or food
Beskrivning

DRUG ALLERGY MULTIPLE | Drug Allergy Severe | FOOD ALLERGY TO MULTIPLE FOOD | Food Allergy Severe | DRUG INTOLERANCE MULTIPLE | Drug intolerance Severe | Food intolerance multiple | Food intolerance Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0743280
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0744084
UMLS CUI [4,1]
C0016470
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0743285
UMLS CUI [6,1]
C0277585
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0149696
UMLS CUI [7,2]
C0439064
UMLS CUI [8,1]
C0149696
UMLS CUI [8,2]
C0205082
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00830076

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Pregnancy test negative
Item
female subjects must have a negative pregnancy test
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Absent
Item
subject has type 2 diabetes and is not currently receiving treatment with an oral aha agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral aha agent for 12 to 18 months prior to the study
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Non-smoker | Tobacco use Absent Duration
Item
subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures | Nervous system disorder Major
Item
subject has a history of stroke, seizures, or major neurological disorders
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Breast Feeding
Item
female subject is breastfeeding
boolean
C0006147 (UMLS CUI [1])
Pharmaceutical Preparations Unable to discontinue | Non-Prescription Drugs Unable to discontinue
Item
subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
boolean
C0013227 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Consumption Alcoholic Beverages U/day
Item
subject consumes more than 3 alcoholic beverages per day
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Consumption Caffeinated beverage U/day
Item
subject consumes more than 6 caffeinated beverages per day
boolean
C0948365 (UMLS CUI [1,1])
C0678438 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Major surgery | Blood Donation Unit Quantity | Blood Loss Unit Quantity
Item
subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C0439148 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3163616 (UMLS CUI [3,1])
C0439148 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Malignant Neoplasms | Exception Skin carcinoma | Exception Cervix carcinoma Specified | Exception Cancer Other Treated
Item
subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
DRUG ALLERGY MULTIPLE | Drug Allergy Severe | FOOD ALLERGY TO MULTIPLE FOOD | Food Allergy Severe | DRUG INTOLERANCE MULTIPLE | Drug intolerance Severe | Food intolerance multiple | Food intolerance Severe
Item
subject has a history of multiple and/or severe allergies or intolerance to drugs or food
boolean
C0743280 (UMLS CUI [1])
C0013182 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0744084 (UMLS CUI [3])
C0016470 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0743285 (UMLS CUI [5])
C0277585 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0149696 (UMLS CUI [7,1])
C0439064 (UMLS CUI [7,2])
C0149696 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
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