ID

33720

Description

Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation; ODM derived from: https://clinicaltrials.gov/show/NCT01179048

Link

https://clinicaltrials.gov/show/NCT01179048

Keywords

Versions (1)
  1. 12/20/18 12/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01179048

English

Eligibility Diabetes NCT01179048

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01179048
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure or age min. 60 years at screening and other specified risk factors of vascular disease
Description

Age | Cardiovascular Diseases | Cerebrovascular Disorders | Peripheral Vascular Diseases | Kidney Failure, Chronic | Chronic heart failure | Risk factors Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0007820
UMLS CUI [4]
C0085096
UMLS CUI [5]
C0022661
UMLS CUI [6]
C0264716
UMLS CUI [7,1]
C0035648
UMLS CUI [7,2]
C0042373
hba1c: 7.0% or above
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (oads) or treated with human nph insulin or long-acting insulin analogue or premixed insulin, alone or in combination with oad(s)
Description

Antidiabetics Absent | Antidiabetics Oral Quantity | Insulin, isophane | 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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
use of a glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (dpp-4) inhibitor within the 3 months prior to screening (trial start)
Description

GLP-1 Receptor Agonist | exenatide | liraglutide | Pramlintide | DPP-4 Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C0537551
UMLS CUI [5]
C3537225
use of insulin other than human nph insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. short-term use of other insulin during this period in connection with intercurrent illness is allowed, at investigator's discretion
Description

Insulin use | Exception NPH insulin | Exception Insulin Analog Active Long-term | Exception Premixed insulin

Data type

boolean

Alias
UMLS CUI [1]
C0240016
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021658
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2825028
UMLS CUI [3,3]
C0205177
UMLS CUI [3,4]
C0443252
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2069057
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Similar models

Eligibility Diabetes NCT01179048

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01179048
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age | Cardiovascular Diseases | Cerebrovascular Disorders | Peripheral Vascular Diseases | Kidney Failure, Chronic | Chronic heart failure | Risk factors Vascular Diseases
Item
age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure or age min. 60 years at screening and other specified risk factors of vascular disease
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0007820 (UMLS CUI [3])
C0085096 (UMLS CUI [4])
C0022661 (UMLS CUI [5])
C0264716 (UMLS CUI [6])
C0035648 (UMLS CUI [7,1])
C0042373 (UMLS CUI [7,2])
Hemoglobin A1c measurement
Item
hba1c: 7.0% or above
boolean
C0474680 (UMLS CUI [1])
Antidiabetics Absent | Antidiabetics Oral Quantity | Insulin, isophane | Insulin Analog Active Long-term | premixed insulin | Combined Modality Therapy
Item
anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (oads) or treated with human nph insulin or long-acting insulin analogue or premixed insulin, alone or in combination with oad(s)
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])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
GLP-1 Receptor Agonist | exenatide | liraglutide | Pramlintide | DPP-4 Inhibitor
Item
use of a glucagon-like peptide-1 (glp-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (dpp-4) inhibitor within the 3 months prior to screening (trial start)
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C3537225 (UMLS CUI [5])
Insulin use | Exception NPH insulin | Exception Insulin Analog Active Long-term | Exception Premixed insulin
Item
use of insulin other than human nph insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. short-term use of other insulin during this period in connection with intercurrent illness is allowed, at investigator's discretion
boolean
C0240016 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021658 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2825028 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
C0443252 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C2069057 (UMLS CUI [4,2])
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