ID

39028

Beschrijving

Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT01654120

Link

https://clinicaltrials.gov/show/NCT01654120

Trefwoorden

Versies (1)
  1. 22-11-19 22-11-19 -
Houder van rechten

See clinicaltrials.gov

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22 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT01654120

Engels

Eligibility Diabetes Mellitus, Type II NCT01654120

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients with type 2 diabetes with hba1c from 6.5 to 10% treated with intensive insulin therapy (mdi or csii, including u-500 insulin-treated patients) using > 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months.
Beschrijving

Gender | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Insulin regime With intensity | Insulin injection Daily Dose Multiple | Continuous subcutaneous infusion of insulin | Humulin insulin | Insulin U/day Quantity | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0474680
UMLS CUI [4,1]
C0557978
UMLS CUI [4,2]
C0522510
UMLS CUI [5,1]
C0199782
UMLS CUI [5,2]
C2348070
UMLS CUI [5,3]
C0439064
UMLS CUI [6]
C0393124
UMLS CUI [7]
C0020171
UMLS CUI [8,1]
C0021641
UMLS CUI [8,2]
C0456683
UMLS CUI [8,3]
C1265611
UMLS CUI [9]
C3846158
2. aged 18 to 80 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. females of child-bearing potential must be using adequate form of contraception.
Beschrijving

Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
4. patient willing to monitor bg four times daily, use cgm, and comply with study-related protocol.
Beschrijving

Blood Glucose Self-Monitoring times/day | Continuous glucose monitoring | Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0439511
UMLS CUI [2]
C4523945
UMLS CUI [3]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 diabetes.
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
2. use of any glp-1 receptor agonist within previous three months.
Beschrijving

GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C2917359
3. use of dpp-4 inhibitors or oral insulin secretagogues within the previous three months.
Beschrijving

Dipeptidyl Peptidase 4 Inhibitors | Pills Releasing Insulin

Datatype

boolean

Alias
UMLS CUI [1]
C2917254
UMLS CUI [2,1]
C0994475
UMLS CUI [2,2]
C1283071
UMLS CUI [2,3]
C0021641
4. use of glucocorticoids (except inhaled).
Beschrijving

Glucocorticoids | Exception Glucocorticoids by Inhalation

Datatype

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017710
UMLS CUI [2,3]
C0205535
5. use of any experimental drug within previous three months.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
6. known or suspected allergy to liraglutide, novolog or levemir.
Beschrijving

Hypersensitivity Liraglutide | Hypersensitivity NovoLog | Hypersensitivity Levemir | Hypersensitivity Suspected Liraglutide | Hypersensitivity Suspected NovoLog | Hypersensitivity Suspected Levemir

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1456408
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0939412
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1314782
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C1456408
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0750491
UMLS CUI [5,3]
C0939412
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C1314782
7. personal or family history of medullary carcinoma of the thyroid or men-2.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
8. concomitant chronic renal disease with creatinine > 1.5%.
Beschrijving

Chronic Kidney Disease | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0201976
9. concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
Beschrijving

Chronic liver disease | Gastrointestinal Disease chronic | Chronic disease | Pancreatitis | Cardiovascular Disease | Exception Exercise-induced angina Stable

Datatype

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0008679
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0007222
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0577698
UMLS CUI [6,3]
C0205360
10. inability or unwillingness to monitor bg, use cgm, or comply with study protocol.
Beschrijving

Blood Glucose Self-Monitoring Unable | Continuous glucose monitoring Unable | Protocol Compliance Unable | Blood Glucose Self-Monitoring Unwilling | Continuous glucose monitoring Unwilling | Protocol Compliance Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4523945
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0005803
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C4523945
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C0525058
UMLS CUI [6,2]
C0558080
11. women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.
Beschrijving

Childbearing Potential Contraceptive methods Unwilling | Pregnancy intended | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1283828
UMLS CUI [3]
C0006147
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Similar models

Eligibility Diabetes Mellitus, Type II NCT01654120

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Insulin regime With intensity | Insulin injection Daily Dose Multiple | Continuous subcutaneous infusion of insulin | Humulin insulin | Insulin U/day Quantity | Other Coding
Item
1. male and female patients with type 2 diabetes with hba1c from 6.5 to 10% treated with intensive insulin therapy (mdi or csii, including u-500 insulin-treated patients) using > 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months.
boolean
C0079399 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0557978 (UMLS CUI [4,1])
C0522510 (UMLS CUI [4,2])
C0199782 (UMLS CUI [5,1])
C2348070 (UMLS CUI [5,2])
C0439064 (UMLS CUI [5,3])
C0393124 (UMLS CUI [6])
C0020171 (UMLS CUI [7])
C0021641 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
C1265611 (UMLS CUI [8,3])
C3846158 (UMLS CUI [9])
Age
Item
2. aged 18 to 80 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
3. females of child-bearing potential must be using adequate form of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Blood Glucose Self-Monitoring times/day | Continuous glucose monitoring | Protocol Compliance
Item
4. patient willing to monitor bg four times daily, use cgm, and comply with study-related protocol.
boolean
C0005803 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C4523945 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
1. type 1 diabetes.
boolean
C0011854 (UMLS CUI [1])
GLP-1 Receptor Agonist
Item
2. use of any glp-1 receptor agonist within previous three months.
boolean
C2917359 (UMLS CUI [1])
Dipeptidyl Peptidase 4 Inhibitors | Pills Releasing Insulin
Item
3. use of dpp-4 inhibitors or oral insulin secretagogues within the previous three months.
boolean
C2917254 (UMLS CUI [1])
C0994475 (UMLS CUI [2,1])
C1283071 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Glucocorticoids | Exception Glucocorticoids by Inhalation
Item
4. use of glucocorticoids (except inhaled).
boolean
C0017710 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017710 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
Investigational New Drugs
Item
5. use of any experimental drug within previous three months.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Liraglutide | Hypersensitivity NovoLog | Hypersensitivity Levemir | Hypersensitivity Suspected Liraglutide | Hypersensitivity Suspected NovoLog | Hypersensitivity Suspected Levemir
Item
6. known or suspected allergy to liraglutide, novolog or levemir.
boolean
C0020517 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0939412 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1314782 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C1456408 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0939412 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1314782 (UMLS CUI [6,3])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
7. personal or family history of medullary carcinoma of the thyroid or men-2.
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Chronic Kidney Disease | Creatinine measurement, serum
Item
8. concomitant chronic renal disease with creatinine > 1.5%.
boolean
C1561643 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Chronic liver disease | Gastrointestinal Disease chronic | Chronic disease | Pancreatitis | Cardiovascular Disease | Exception Exercise-induced angina Stable
Item
9. concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
boolean
C0341439 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0577698 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Blood Glucose Self-Monitoring Unable | Continuous glucose monitoring Unable | Protocol Compliance Unable | Blood Glucose Self-Monitoring Unwilling | Continuous glucose monitoring Unwilling | Protocol Compliance Unwilling
Item
10. inability or unwillingness to monitor bg, use cgm, or comply with study protocol.
boolean
C0005803 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4523945 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0005803 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C4523945 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0525058 (UMLS CUI [6,1])
C0558080 (UMLS CUI [6,2])
Childbearing Potential Contraceptive methods Unwilling | Pregnancy intended | Breast Feeding
Item
11. women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
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