ID

43892

Beskrivning

Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00376038

Länk

https://clinicaltrials.gov/show/NCT00376038

Nyckelord

Versioner (2)
  1. 2017-06-30 2017-06-30 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00376038

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00376038

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
have a body mass index within range 22 to 35kg/m2 inclusive.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
females who meet above criteria must be physiologically incapable of becoming pregnant (i.e., surgically sterilized, or post-menopausal per protocol definition).
Beskrivning

Female Sterilization | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently taking insulin therapy.
Beskrivning

Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1]
C0557978
have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
Beskrivning

Heart Diseases | Liver diseases | Hematological Disease | nervous system disorder | Kidney Diseases | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0006826
have a history of stomach, liver, kidney, or other disease that with interfere with taking the study drug.
Beskrivning

Stomach Disease Interferes with Investigational New Drugs | Liver disease Interferes with Investigational New Drugs | Kidney Disease Interferes with Investigational New Drugs | Disease Interferes with Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038354
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0013230
are currently using diuretics, oral or injectable corticosteroids (inhaled &
Beskrivning

Diuretics | Adrenal Cortex Hormones Oral | corticosteroids injection

Datatyp

boolean

Alias
UMLS CUI [1]
C0012798
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C2095490
intranasal corticosteroids are permitted), or other medications that would cause you to deplete your fluid balance in your body; currently taking stable regimens for heart conditions; currently using prescription or non-prescription drugs within 7 days of starting the study that may interfere with the study drug.
Beskrivning

Inhaled steroids Excluded | Adrenal Cortex Hormones Intranasal Excluded | Pharmaceutical Preparations Causing Depletion Fluid Balance | Regimen Stable Heart condition | Pharmaceutical Preparations Interfere with Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2065041
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522019
UMLS CUI [2,3]
C2828389
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0333668
UMLS CUI [3,4]
C0016284
UMLS CUI [4,1]
C0040808
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C3842523
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0013230
would donate more than 450 ml of blood over a 2 month period.
Beskrivning

Blood Donation Blood Amount

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1265611
physician does not think it is a good idea for you to participate in the trial.- had a urinary tract infection or bladder infection in the last month. - are currently drinking more than 2 beers, 1 glass of wine, or 1 glass of spirits daily.
Beskrivning

Study Subject Participation Status Unfavorable | Urinary tract infection | Infective cystitis | Drinking Beer Quantity Daily | Drinking Wine Quantity Daily | Drinking Spirit Quantity Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3640815
UMLS CUI [2]
C0042029
UMLS CUI [3]
C0600041
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C0004922
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0332173
UMLS CUI [5,1]
C0001948
UMLS CUI [5,2]
C0043188
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C0332173
UMLS CUI [6,1]
C0001948
UMLS CUI [6,2]
C0301611
UMLS CUI [6,3]
C1265611
UMLS CUI [6,4]
C0332173
have a positive urine drug screen test.
Beskrivning

Urine drug screen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0743300
plan to change your smoking habits during the course of the trial.
Beskrivning

Tobacco use Habits Change Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C2242848
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C1301732
have hepatitis c, hepatitis b, or hiv. -
Beskrivning

Hepatitis C | Hepatitis B | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
have a lab or ekg abnormality. - high or low blood pressure.
Beskrivning

Laboratory test result abnormal | ECG abnormality | Hypertensive disease | Hypotension

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0522055
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0020649
have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
Beskrivning

Investigational New Drugs | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
are a male subject unwilling to abstain or use protection during intercourse.
Beskrivning

Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00376038

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
have a body mass index within range 22 to 35kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Female Sterilization | Postmenopausal state
Item
females who meet above criteria must be physiologically incapable of becoming pregnant (i.e., surgically sterilized, or post-menopausal per protocol definition).
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Insulin regime
Item
are currently taking insulin therapy.
boolean
C0557978 (UMLS CUI [1])
Heart Diseases | Liver diseases | Hematological Disease | nervous system disorder | Kidney Diseases | Malignant Neoplasms
Item
have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
boolean
C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
Stomach Disease Interferes with Investigational New Drugs | Liver disease Interferes with Investigational New Drugs | Kidney Disease Interferes with Investigational New Drugs | Disease Interferes with Investigational New Drugs
Item
have a history of stomach, liver, kidney, or other disease that with interfere with taking the study drug.
boolean
C0038354 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0022658 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
Diuretics | Adrenal Cortex Hormones Oral | corticosteroids injection
Item
are currently using diuretics, oral or injectable corticosteroids (inhaled &
boolean
C0012798 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2095490 (UMLS CUI [3])
Inhaled steroids Excluded | Adrenal Cortex Hormones Intranasal Excluded | Pharmaceutical Preparations Causing Depletion Fluid Balance | Regimen Stable Heart condition | Pharmaceutical Preparations Interfere with Investigational New Drugs
Item
intranasal corticosteroids are permitted), or other medications that would cause you to deplete your fluid balance in your body; currently taking stable regimens for heart conditions; currently using prescription or non-prescription drugs within 7 days of starting the study that may interfere with the study drug.
boolean
C2065041 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1522019 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0333668 (UMLS CUI [3,3])
C0016284 (UMLS CUI [3,4])
C0040808 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C3842523 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
Blood Donation Blood Amount
Item
would donate more than 450 ml of blood over a 2 month period.
boolean
C0005794 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Study Subject Participation Status Unfavorable | Urinary tract infection | Infective cystitis | Drinking Beer Quantity Daily | Drinking Wine Quantity Daily | Drinking Spirit Quantity Daily
Item
physician does not think it is a good idea for you to participate in the trial.- had a urinary tract infection or bladder infection in the last month. - are currently drinking more than 2 beers, 1 glass of wine, or 1 glass of spirits daily.
boolean
C2348568 (UMLS CUI [1,1])
C3640815 (UMLS CUI [1,2])
C0042029 (UMLS CUI [2])
C0600041 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C0004922 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332173 (UMLS CUI [4,4])
C0001948 (UMLS CUI [5,1])
C0043188 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0332173 (UMLS CUI [5,4])
C0001948 (UMLS CUI [6,1])
C0301611 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0332173 (UMLS CUI [6,4])
Urine drug screen positive
Item
have a positive urine drug screen test.
boolean
C0743300 (UMLS CUI [1])
Tobacco use Habits Change Planned
Item
plan to change your smoking habits during the course of the trial.
boolean
C0543414 (UMLS CUI [1,1])
C2242848 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Hepatitis C | Hepatitis B | HIV Infection
Item
have hepatitis c, hepatitis b, or hiv. -
boolean
C0019196 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Laboratory test result abnormal | ECG abnormality | Hypertensive disease | Hypotension
Item
have a lab or ekg abnormality. - high or low blood pressure.
boolean
C0438215 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0020649 (UMLS CUI [4])
Investigational New Drugs | Investigational Medical Device
Item
have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling
Item
are a male subject unwilling to abstain or use protection during intercourse.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Tillbaka till toppen 

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