ID

23273

Descripción

A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002); ODM derived from: https://clinicaltrials.gov/show/NCT02012166

Link

https://clinicaltrials.gov/show/NCT02012166

Palabras clave

Versiones (1)
  1. 1/7/17 1/7/17 -
Subido en

1 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02012166

Inglés

Eligibility Type 2 Diabetes Mellitus NCT02012166

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
good health
Descripción

Overall Well Being

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3813622
body mass index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
non-smoker for at least 6 months
Descripción

Non-smoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
willing to avoid strenuous physical activity
Descripción

Strenuous Exercise Avoidance Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0600109
willing to avoid alcohol, caffeine, and grapefruit juice consumption
Descripción

Alcohol consumption Avoidance Willing | Caffeine consumption Avoidance Willing | Grapefruit juice Intake Avoidance Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0948365
UMLS CUI [2,2]
C0870186
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0452456
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0870186
UMLS CUI [3,4]
C0600109
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery
Descripción

Kidney Diseases | nervous system disorder | Gastrointestinal Diseases | Respiration Disorders | Gastrointestinal Surgical Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0524722
history of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food
Descripción

Multiple allergies Pharmaceutical Preparations | Multiple allergies Non-Prescription Drugs | Multiple allergies Investigational New Drugs | Multiple allergies Food Investigational | Drug Allergy Severe | Hypersensitivity Severe Non-Prescription Drugs | Hypersensitivity Severe Investigational New Drugs | Hypersensitivity Severe Food Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0740281
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0740281
UMLS CUI [2,2]
C0013231
UMLS CUI [3,1]
C0740281
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0740281
UMLS CUI [4,2]
C0016452
UMLS CUI [4,3]
C1517586
UMLS CUI [5,1]
C0013182
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0013231
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C0013230
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0016452
UMLS CUI [8,4]
C1517586
history of any cardiovascular/cardiac disease
Descripción

Cardiovascular Diseases | Heart Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018799
history of any hepatic disease and primary biliary cirrhosis
Descripción

Liver diseases | Primary biliary cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0008312
history of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes
Descripción

Hypoglycemia | Intolerance to Glucose | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020615
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0017725
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0011860
requires or anticipates use of prescription or nonprescription medications, including herbal remedies
Descripción

Pharmaceutical Preparations Patient need for | Non-Prescription Drugs Patient need for | Plant Preparations Patient need for | Pharmaceutical Preparations Anticipated | Non-Prescription Drugs Anticipated | Plant Preparations Anticipated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0949854
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C3840775
UMLS CUI [5,1]
C0013231
UMLS CUI [5,2]
C3840775
UMLS CUI [6,1]
C0949854
UMLS CUI [6,2]
C3840775
a user of any illicit drugs or a history of drug or alcohol abuse
Descripción

Illicit drug use | Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0038586
surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation
Descripción

Operative Surgical Procedures | Blood Donation | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0005794
UMLS CUI [3]
C2348568
history of hypersensitivity to insulin, glucagon, or sandostatine®.
Descripción

Insulin allergy | Glucagon allergy | Hypersensitivity Sandostatin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2]
C0571580
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0678117
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02012166

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Overall Well Being
Item
good health
boolean
C3813622 (UMLS CUI [1])
Body mass index
Item
body mass index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor
boolean
C1305855 (UMLS CUI [1])
Non-smoker
Item
non-smoker for at least 6 months
boolean
C0337672 (UMLS CUI [1])
Strenuous Exercise Avoidance Willing
Item
willing to avoid strenuous physical activity
boolean
C1514989 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Alcohol consumption Avoidance Willing | Caffeine consumption Avoidance Willing | Grapefruit juice Intake Avoidance Willing
Item
willing to avoid alcohol, caffeine, and grapefruit juice consumption
boolean
C0001948 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0948365 (UMLS CUI [2,1])
C0870186 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0452456 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0870186 (UMLS CUI [3,3])
C0600109 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Kidney Diseases | nervous system disorder | Gastrointestinal Diseases | Respiration Disorders | Gastrointestinal Surgical Procedure
Item
history of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery
boolean
C0022658 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0524722 (UMLS CUI [5])
Multiple allergies Pharmaceutical Preparations | Multiple allergies Non-Prescription Drugs | Multiple allergies Investigational New Drugs | Multiple allergies Food Investigational | Drug Allergy Severe | Hypersensitivity Severe Non-Prescription Drugs | Hypersensitivity Severe Investigational New Drugs | Hypersensitivity Severe Food Investigational
Item
history of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food
boolean
C0740281 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0740281 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0740281 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0740281 (UMLS CUI [4,1])
C0016452 (UMLS CUI [4,2])
C1517586 (UMLS CUI [4,3])
C0013182 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0013231 (UMLS CUI [6,3])
C0020517 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0013230 (UMLS CUI [7,3])
C0020517 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0016452 (UMLS CUI [8,3])
C1517586 (UMLS CUI [8,4])
Cardiovascular Diseases | Heart Diseases
Item
history of any cardiovascular/cardiac disease
boolean
C0007222 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Liver diseases | Primary biliary cirrhosis
Item
history of any hepatic disease and primary biliary cirrhosis
boolean
C0023895 (UMLS CUI [1])
C0008312 (UMLS CUI [2])
Hypoglycemia | Intolerance to Glucose | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
history of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes
boolean
C0020615 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0017725 (UMLS CUI [2,2])
C0011854 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
Pharmaceutical Preparations Patient need for | Non-Prescription Drugs Patient need for | Plant Preparations Patient need for | Pharmaceutical Preparations Anticipated | Non-Prescription Drugs Anticipated | Plant Preparations Anticipated
Item
requires or anticipates use of prescription or nonprescription medications, including herbal remedies
boolean
C0013227 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0949854 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C3840775 (UMLS CUI [4,2])
C0013231 (UMLS CUI [5,1])
C3840775 (UMLS CUI [5,2])
C0949854 (UMLS CUI [6,1])
C3840775 (UMLS CUI [6,2])
Illicit drug use | Substance Use Disorders
Item
a user of any illicit drugs or a history of drug or alcohol abuse
boolean
C0281875 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Operative Surgical Procedures | Blood Donation | Study Subject Participation Status
Item
surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation
boolean
C0543467 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Insulin allergy | Glucagon allergy | Hypersensitivity Sandostatin
Item
history of hypersensitivity to insulin, glucagon, or sandostatine®.
boolean
C0571622 (UMLS CUI [1])
C0571580 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0678117 (UMLS CUI [3,2])
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