ID

32916

Descripción

A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00902161

Link

https://clinicaltrials.gov/show/NCT00902161

Palabras clave

Versiones (1)
  1. 20/11/18 20/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00902161

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00902161

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has type 2 diabetes (t2dm)
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
participant is either: not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (ppar-gamma) agonist (e.g. avandia); or on a combination of no more than two antihyperglycemic medications that are not ppar-gamma) agonists
Descripción

Oral hypoglycemic Absent | Oral hypoglycemic Single | Exception PPAR-gamma Agonist | Exception Avandia | Combination Hypoglycemic Agents Quantity | Exception PPAR-gamma Agonist

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2917405
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0875967
UMLS CUI [5,1]
C0205195
UMLS CUI [5,2]
C0020616
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2917405
participant has not received insulin for at least 6 months
Descripción

Insulin Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
participant has not been treated with a ppar-gamma agonist for at least 12 weeks
Descripción

PPAR gamma Agonists Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2916798
UMLS CUI [1,2]
C0332197
participant has been a nonsmoker for at least 6 months
Descripción

Non-smoker Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0337672
UMLS CUI [1,2]
C0449238
female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods
Descripción

Gender | Pregnancy Absent | Pregnancy Unlikely | Female Sterilization | Postmenopausal state | Heterosexual activity Absent | Contraceptive methods Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750558
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0232970
UMLS CUI [6,1]
C4272228
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has a history of stroke, seizures, or neurological disorders
Descripción

Cerebrovascular accident | Seizures | Nervous system disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0027765
participant cannot tolerate insulin or propranolol
Descripción

Intolerance to Insulin | Intolerance to Propranolol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0021641
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0033497
participant has a history of asthma, emphysema or chronic bronchitis
Descripción

Asthma | Emphysema | Bronchitis, Chronic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C0034067
UMLS CUI [3]
C0008677
participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
Descripción

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

Tipo de datos

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
participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
Descripción

Pharmaceutical Preparations Affecting Immune system | Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0020962
UMLS CUI [2]
C0001617
participant has a history of heart failure or coronary artery disease
Descripción

Heart failure | Coronary Artery Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C1956346
participant has a history of uncontrolled high blood pressure
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
participant is human immunodeficiency (hiv), hepatitis b or hepatitis c positive
Descripción

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
participant has a history of type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dl (3.1 mol/l) without symptoms of hypoglycemia.
Descripción

Loss of hypoglycemic warning | Blood glucose concentration | Symptoms Absent Hypoglycemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C2585282
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0020615
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00902161

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
participant has type 2 diabetes (t2dm)
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic Absent | Oral hypoglycemic Single | Exception PPAR-gamma Agonist | Exception Avandia | Combination Hypoglycemic Agents Quantity | Exception PPAR-gamma Agonist
Item
participant is either: not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (ppar-gamma) agonist (e.g. avandia); or on a combination of no more than two antihyperglycemic medications that are not ppar-gamma) agonists
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2917405 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0875967 (UMLS CUI [4,2])
C0205195 (UMLS CUI [5,1])
C0020616 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C2917405 (UMLS CUI [6,2])
Insulin Absent
Item
participant has not received insulin for at least 6 months
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
PPAR gamma Agonists Absent
Item
participant has not been treated with a ppar-gamma agonist for at least 12 weeks
boolean
C2916798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Non-smoker Duration
Item
participant has been a nonsmoker for at least 6 months
boolean
C0337672 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Gender | Pregnancy Absent | Pregnancy Unlikely | Female Sterilization | Postmenopausal state | Heterosexual activity Absent | Contraceptive methods Quantity
Item
female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C4272228 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0700589 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures | Nervous system disorder
Item
participant has a history of stroke, seizures, or neurological disorders
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
Intolerance to Insulin | Intolerance to Propranolol
Item
participant cannot tolerate insulin or propranolol
boolean
C1744706 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0033497 (UMLS CUI [2,2])
Asthma | Emphysema | Bronchitis, Chronic
Item
participant has a history of asthma, emphysema or chronic bronchitis
boolean
C0004096 (UMLS CUI [1])
C0034067 (UMLS CUI [2])
C0008677 (UMLS CUI [3])
Weight Reduction Program | Maintenance Phase Absent | Weight-Loss Agents
Item
participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Immune system | Adrenal Cortex Hormones
Item
participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0020962 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
Heart failure | Coronary Artery Disease
Item
participant has a history of heart failure or coronary artery disease
boolean
C0018801 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
Uncontrolled hypertension
Item
participant has a history of uncontrolled high blood pressure
boolean
C1868885 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
participant is human immunodeficiency (hiv), hepatitis b or hepatitis c positive
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent
Item
participant has a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Loss of hypoglycemic warning | Blood glucose concentration | Symptoms Absent Hypoglycemia
Item
participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dl (3.1 mol/l) without symptoms of hypoglycemia.
boolean
C0342317 (UMLS CUI [1])
C2585282 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0020615 (UMLS CUI [3,3])
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