ID

35721

Beschrijving

Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02465515

Link

https://clinicaltrials.gov/show/NCT02465515

Trefwoorden

Versies (1)
  1. 18-03-19 18-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02465515

Engels

Eligibility Diabetes Mellitus NCT02465515

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women at least 40 years old. women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
Beschrijving

Age | Postmenopausal state | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
diagnosis of type 2 diabetes.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
Beschrijving

Cardiovascular Disease | Coronary Artery Disease | Cerebrovascular Disorder | Peripheral Arterial Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0007820
UMLS CUI [4]
C1704436
hba1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
able and willing to provide informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severely reduced kidney function: egfr <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
Beschrijving

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Renal Replacement Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
UMLS CUI [3]
C0206074
use of a glp-1 receptor agonist at screening.
Beschrijving

GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
severe gastroparesis
Beschrijving

Gastroparesis Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152020
UMLS CUI [1,2]
C0205082
history of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
Beschrijving

Pancreatitis | At risk Pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0030305
personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (men-2). personal history of pancreatic neuroendocrine tumours.
Beschrijving

History of medullary carcinoma of thyroid | Family history Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia Type | Islet Cell Tumor

Datatype

boolean

Alias
UMLS CUI [1]
C1997422
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0238462
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4]
C0242363
medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
Beschrijving

Medical History Limiting Investigational Therapy | Medical History Limiting Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0949266
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C2732579
breastfeeding, pregnancy, or planning a pregnancy during the course of the study. note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
Beschrijving

Breast Feeding | Pregnancy | Pregnancy, Planned | Childbearing Potential Pregnancy Test

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
known allergy to any glp-1 receptor agonist or excipients of albiglutide.
Beschrijving

Hypersensitivity GLP-1 Receptor Agonist | Hypersensitivity Albiglutide Excipient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2917359
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2607479
UMLS CUI [2,3]
C0015237
use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
Beschrijving

Investigational New Drugs | Study Subject Participation Status | Investigational Medical Device

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C2346570
any other reason the investigator deems the subject to be unsuitable for the study.
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Diabetes Mellitus NCT02465515

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal state | Gender Contraceptive methods
Item
men or women at least 40 years old. women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Cardiovascular Disease | Coronary Artery Disease | Cerebrovascular Disorder | Peripheral Arterial Disease
Item
established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
boolean
C0007222 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C1704436 (UMLS CUI [4])
Hemoglobin A1c measurement
Item
hba1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
able and willing to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Renal Replacement Therapy
Item
severely reduced kidney function: egfr <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0206074 (UMLS CUI [3])
GLP-1 Receptor Agonist
Item
use of a glp-1 receptor agonist at screening.
boolean
C2917359 (UMLS CUI [1])
Gastroparesis Severe
Item
severe gastroparesis
boolean
C0152020 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pancreatitis | At risk Pancreatitis
Item
history of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
boolean
C0030305 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0030305 (UMLS CUI [2,2])
History of medullary carcinoma of thyroid | Family history Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia Type | Islet Cell Tumor
Item
personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (men-2). personal history of pancreatic neuroendocrine tumours.
boolean
C1997422 (UMLS CUI [1])
C0241889 (UMLS CUI [2,1])
C0238462 (UMLS CUI [2,2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0242363 (UMLS CUI [4])
Medical History Limiting Investigational Therapy | Medical History Limiting Completion of clinical trial
Item
medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
boolean
C0262926 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0949266 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Breast Feeding | Pregnancy | Pregnancy, Planned | Childbearing Potential Pregnancy Test
Item
breastfeeding, pregnancy, or planning a pregnancy during the course of the study. note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
Hypersensitivity GLP-1 Receptor Agonist | Hypersensitivity Albiglutide Excipient
Item
known allergy to any glp-1 receptor agonist or excipients of albiglutide.
boolean
C0020517 (UMLS CUI [1,1])
C2917359 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Investigational New Drugs | Study Subject Participation Status | Investigational Medical Device
Item
use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
any other reason the investigator deems the subject to be unsuitable for the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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