ID

43892

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00376038

Stichworte

Versionen (2)
  1. 30.06.17 30.06.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Type 2 Diabetes Mellitus NCT00376038

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00376038

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

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

Body mass index

Datentyp

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).
Beschreibung

Female Sterilization | Postmenopausal state

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
are currently taking insulin therapy.
Beschreibung

Insulin regime

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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 &
Beschreibung

Diuretics | Adrenal Cortex Hormones Oral | corticosteroids injection

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Blood Donation Blood Amount

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Urine drug screen positive

Datentyp

boolean

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

Tobacco use Habits Change Planned

Datentyp

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. -
Beschreibung

Hepatitis C | Hepatitis B | HIV Infection

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

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

Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00376038

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video