ID

20651

Beschrijving

GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00291356

Link

https://clinicaltrials.gov/show/NCT00291356

Trefwoorden

Versies (1)
  1. 08-03-17 08-03-17 -
Geüploaded op

8 maart 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Diabetes Mellitus, Type 2 NCT00291356

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00291356

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
hba1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
taking 850mg or more per day metformin, but not taking any other diabetes medications.
Beschrijving

Metformin U/day | Antidiabetics Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
Beschrijving

Antidiabetics Discontinue Able | Antidiabetics Discontinue Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0600109
diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their hba1c is within 7.5 to 9.0.
Beschrijving

Antidiabetics Absent | Diabetes mellitus under control Diet | Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C2062378
UMLS CUI [2,2]
C0011878
UMLS CUI [3]
C0202054
women may be eligible if they are post-menopausal or surgically sterile.
Beschrijving

Postmenopausal state | Female Sterilization

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
if taking ace inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial.
Beschrijving

Angiotensin-Converting Enzyme Inhibitors Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable | Calcium Channel Blockers Dose Stable | Hydroxymethylglutaryl-CoA Reductase Inhibitors Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0006684
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0360714
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
using illicit drugs, or have antibodies to hepatitis b, hepatitis c, or hiv.
Beschrijving

Illicit drug use | Hepatitis B Antibodies | Hepatitis C Antibodies | HIV Antibodies

Datatype

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0019164
UMLS CUI [3]
C0166049
UMLS CUI [4]
C0019683
have any major health problems other than type 2 diabetes.
Beschrijving

Health Problem Major | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0033213
UMLS CUI [1,3]
C0205164
UMLS CUI [2]
C0011860
require insulin therapy or oral antidiabetic medication other than metformin.
Beschrijving

Insulin regime Patient need for | Antidiabetics Oral Patient need for | Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0686904
UMLS CUI [3]
C0025598
subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
Beschrijving

Urinary tract infection | Kidney Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0042029
UMLS CUI [2]
C0022658
subjects with either low or high blood pressure.
Beschrijving

Hypotension | Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0020538
men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.
Beschrijving

Gender Sexual Abstinence Unwilling | Gender Male condom Unwilling | Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling

Datatype

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]
C0009653
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0558080
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00291356

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
boolean
C0019018 (UMLS CUI [1])
Metformin U/day | Antidiabetics Absent
Item
taking 850mg or more per day metformin, but not taking any other diabetes medications.
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Antidiabetics Discontinue Able | Antidiabetics Discontinue Willing
Item
must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
boolean
C0935929 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Antidiabetics Absent | Diabetes mellitus under control Diet | Glucohemoglobin measurement
Item
diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their hba1c is within 7.5 to 9.0.
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2062378 (UMLS CUI [2,1])
C0011878 (UMLS CUI [2,2])
C0202054 (UMLS CUI [3])
Postmenopausal state | Female Sterilization
Item
women may be eligible if they are post-menopausal or surgically sterile.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable | Calcium Channel Blockers Dose Stable | Hydroxymethylglutaryl-CoA Reductase Inhibitors Dose Stable
Item
if taking ace inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial.
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0304516 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0006684 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0360714 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Illicit drug use | Hepatitis B Antibodies | Hepatitis C Antibodies | HIV Antibodies
Item
using illicit drugs, or have antibodies to hepatitis b, hepatitis c, or hiv.
boolean
C0281875 (UMLS CUI [1])
C0019164 (UMLS CUI [2])
C0166049 (UMLS CUI [3])
C0019683 (UMLS CUI [4])
Health Problem Major | Diabetes Mellitus, Non-Insulin-Dependent
Item
have any major health problems other than type 2 diabetes.
boolean
C0018684 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0011860 (UMLS CUI [2])
Insulin regime Patient need for | Antidiabetics Oral Patient need for | Metformin
Item
require insulin therapy or oral antidiabetic medication other than metformin.
boolean
C0557978 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3])
Urinary tract infection | Kidney Disease
Item
subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
boolean
C0042029 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Hypotension | Hypertensive disease
Item
subjects with either low or high blood pressure.
boolean
C0020649 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
Gender Sexual Abstinence Unwilling | Gender Male condom Unwilling | Pregnancy | Breast Feeding | Gender Contraceptive methods Unwilling
Item
men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0009653 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
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