ID

38952

Description

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01720446

Link

https://clinicaltrials.gov/show/NCT01720446

Keywords

Versions (1)
  1. 11/15/19 11/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01720446

English

Eligibility Diabetes NCT01720446

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01720446
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women with type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease
Description

Age | Cardiovascular Disease | Cardiovascular Disease Evidence Subclinical

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007222
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0205211
anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (oads), or treated with human neutral protamin hagedorn (nph) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two oads
Description

Antidiabetics Absent | Antidiabetics Oral Quantity | NPH insulin | Insulin Analog Active Long-term | Premixed insulin | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0021658
UMLS CUI [4,1]
C2825028
UMLS CUI [4,2]
C0205177
UMLS CUI [4,3]
C0443252
UMLS CUI [5]
C2069057
UMLS CUI [6]
C0009429
hba1c above or equal to 7.0% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
use of glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
Description

GLP-1 Receptor Agonist | exenatide | liraglutide | Pramlintide

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C0537551
use of any dipeptidyl peptidase 4 (dpp-iv) inhibitor within 30 days prior to screening
Description

Dipeptidyl Peptidase 4 Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C3537161
treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
Description

Insulin regime | Exception Basal insulin | Exception Premixed insulin | Exception Insulin use short-term | Relationship Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0650607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2069057
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0240016
UMLS CUI [4,3]
C0443303
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0009488
acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
Description

Poor glycemic control | Requirement Intensification therapy Immediate | Prevention Complications of Diabetes Mellitus | Prevention Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1511484
UMLS CUI [2,3]
C0205253
UMLS CUI [3,1]
C2700409
UMLS CUI [3,2]
C0342257
UMLS CUI [4,1]
C2700409
UMLS CUI [4,2]
C0011880
history of chronic pancreatitis or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
acute coronary or cerebro-vascular event within 90 days prior to randomisation
Description

Acute Coronary Syndrome | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
currently planned coronary, carotid or peripheral artery revascularisation
Description

Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C3495793
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1096418
UMLS CUI [3,2]
C1301732
chronic heart failure new york heart association (nyha) class iv
Description

Chronic heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
personal or family history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma
Description

Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type | Familial medullary thyroid carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0027662
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C4039247
UMLS CUI [2,2]
C0332307
UMLS CUI [3]
C1833921
personal history of non-familial medullary thyroid carcinoma
Description

Medullary carcinoma of thyroid

Data type

boolean

Alias
UMLS CUI [1]
C0238462
screening calcitonin above or equal to 50 ng/l
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
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Similar models

Eligibility Diabetes NCT01720446

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01720446
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
men and women with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Age | Cardiovascular Disease | Cardiovascular Disease Evidence Subclinical
Item
age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0205211 (UMLS CUI [3,3])
Antidiabetics Absent | Antidiabetics Oral Quantity | NPH insulin | Insulin Analog Active Long-term | Premixed insulin | Combined Modality Therapy
Item
anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (oads), or treated with human neutral protamin hagedorn (nph) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two oads
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0021658 (UMLS CUI [3])
C2825028 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C2069057 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
Hemoglobin A1c measurement
Item
hba1c above or equal to 7.0% at screening
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
GLP-1 Receptor Agonist | exenatide | liraglutide | Pramlintide
Item
use of glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
Dipeptidyl Peptidase 4 Inhibitor
Item
use of any dipeptidyl peptidase 4 (dpp-iv) inhibitor within 30 days prior to screening
boolean
C3537161 (UMLS CUI [1])
Insulin regime | Exception Basal insulin | Exception Premixed insulin | Exception Insulin use short-term | Relationship Comorbidity
Item
treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2069057 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0240016 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C0439849 (UMLS CUI [5,1])
C0009488 (UMLS CUI [5,2])
Poor glycemic control | Requirement Intensification therapy Immediate | Prevention Complications of Diabetes Mellitus | Prevention Diabetic Ketoacidosis
Item
acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
boolean
C0342299 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C1511484 (UMLS CUI [2,2])
C0205253 (UMLS CUI [2,3])
C2700409 (UMLS CUI [3,1])
C0342257 (UMLS CUI [3,2])
C2700409 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary or cerebro-vascular event within 90 days prior to randomisation
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
currently planned coronary, carotid or peripheral artery revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3495793 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1096418 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Chronic heart failure New York Heart Association Classification
Item
chronic heart failure new york heart association (nyha) class iv
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type | Familial medullary thyroid carcinoma
Item
personal or family history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma
boolean
C0027662 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4039247 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
Medullary carcinoma of thyroid
Item
personal history of non-familial medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
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