ID

32888

Beschrijving

A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus (MK-3577-009); ODM derived from: https://clinicaltrials.gov/show/NCT00868790

Link

https://clinicaltrials.gov/show/NCT00868790

Trefwoorden

Versies (1)
  1. 19-11-18 19-11-18 -
Houder van rechten

See clinicaltrials.gov

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19 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00868790

Engels

Eligibility Type 2 Diabetes Mellitus NCT00868790

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
patient is either not taking antihyperglycemic medications for the last 10 weeks or is taking a single oral antihyperglycemic medication (but not a pparg agonist) or is taking a low-dose combination oral antihyperglycemic medication (not a pparg agonist) at dose less than or equal to 50% of the maximum dose
Beschrijving

Hypoglycemic Agents Absent | Oral hypoglycemic Single | Exception PPAR gamma Agonist | Oral hypoglycemic Combination Low dose | Exception PPPAR gamma Agonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2916798
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C0205195
UMLS CUI [4,3]
C0445550
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2916798
female patient is unable to have children
Beschrijving

Female infertility

Datatype

boolean

Alias
UMLS CUI [1]
C0021361
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of type 1 diabetes or ketoacidosis
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
patient has been treated with a pparg agonist in the last 12 weeks
Beschrijving

PPAR gamma Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C2916798
patient has been treated with insulin in the last 12 weeks
Beschrijving

Insulin

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
patient has had prescription lipid-modifying drug therapy in the last 12 weeks
Beschrijving

LIPID MODIFYING AGENTS

Datatype

boolean

Alias
UMLS CUI [1]
C3653535
patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
Beschrijving

Weight Reduction Program | Maintenance Phase Absent | Weight-Loss Agents

Datatype

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0376606
patient has a history of coronary artery disease
Beschrijving

Coronary Artery Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
patient has had a stroke or transient ischemic attack
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
patient has congestive heart failure
Beschrijving

Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
patient is hiv positive
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
patient has a history of cancer except certain skin or cervical cancers
Beschrijving

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

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
patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
Beschrijving

Alcohol Abstinence Unwilling | Status pre- Clinic Visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678274
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0008952
patient is breast-feeding
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
patient will donate eggs during the study
Beschrijving

Egg Donation Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C4053456
UMLS CUI [1,2]
C1301732
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00868790

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patient has type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hypoglycemic Agents Absent | Oral hypoglycemic Single | Exception PPAR gamma Agonist | Oral hypoglycemic Combination Low dose | Exception PPPAR gamma Agonists
Item
patient is either not taking antihyperglycemic medications for the last 10 weeks or is taking a single oral antihyperglycemic medication (but not a pparg agonist) or is taking a low-dose combination oral antihyperglycemic medication (not a pparg agonist) at dose less than or equal to 50% of the maximum dose
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2916798 (UMLS CUI [3,2])
C0359086 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2916798 (UMLS CUI [5,2])
Female infertility
Item
female patient is unable to have children
boolean
C0021361 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
patient has a history of type 1 diabetes or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
PPAR gamma Agonist
Item
patient has been treated with a pparg agonist in the last 12 weeks
boolean
C2916798 (UMLS CUI [1])
Insulin
Item
patient has been treated with insulin in the last 12 weeks
boolean
C0021641 (UMLS CUI [1])
LIPID MODIFYING AGENTS
Item
patient has had prescription lipid-modifying drug therapy in the last 12 weeks
boolean
C3653535 (UMLS CUI [1])
Weight Reduction Program | Maintenance Phase Absent | Weight-Loss Agents
Item
patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3])
Coronary Artery Disease
Item
patient has a history of coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
patient has had a stroke or transient ischemic attack
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Congestive heart failure
Item
patient has congestive heart failure
boolean
C0018802 (UMLS CUI [1])
HIV Seropositivity
Item
patient is hiv positive
boolean
C0019699 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma Some | Exception Cervix carcinoma Some
Item
patient has a history of cancer except certain skin or cervical cancers
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])
Alcohol Abstinence Unwilling | Status pre- Clinic Visit
Item
patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
boolean
C0678274 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
Breast Feeding
Item
patient is breast-feeding
boolean
C0006147 (UMLS CUI [1])
Egg Donation Planned
Item
patient will donate eggs during the study
boolean
C4053456 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
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