ID

37430

Beskrivning

Investigating the Effect of Liraglutide on the Endogenous Glucose Production During in Tye 1 Diabetes Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02408705

Länk

https://clinicaltrials.gov/show/NCT02408705

Nyckelord

Versioner (1)
  1. 2019-07-26 2019-07-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT02408705

Engelsk

Eligibility Type 1 Diabetes Mellitus NCT02408705

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. type 1 diabetes mellitus as diagnosed (including i - iii):
Beskrivning

Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
i. history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria ii. positive results for at least one of four islet antibodies (glutamic acid decarboxylase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies) iii. residual basal fasting c-peptide of ≥ 0.1 nmol/l
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Hyperglycemia | Ketonuria | Anti-islet cell antibody positive Quantity | Glutamate Decarboxylase | Protein Tyrosine Phosphatase | Zinc transporter 8 | Islet cell antibody | Fasting C-peptide level Basal Residual

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0020456
UMLS CUI [3]
C0162275
UMLS CUI [4,1]
C0877212
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0017785
UMLS CUI [6]
C0085536
UMLS CUI [7]
C4019440
UMLS CUI [8]
C0063900
UMLS CUI [9,1]
C2208720
UMLS CUI [9,2]
C0205112
UMLS CUI [9,3]
C1609982
3. male or female, aged 18 - 64 years (both inclusive)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. body mass index (bmi) 20.0 - 25.0 kg/m2 (both inclusive)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
5. hba1c 42 - 80 mmol/mol (6.0-9.5%)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
6. treated with daily insulin injections or continuous s.c. insulin infusion (csii) ≥ 1 months. stable insulin dose as judged by the investigator
Beskrivning

Insulin injection Daily | Continuous subcutaneous infusion of insulin | Insulin Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0332173
UMLS CUI [2]
C0393124
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known or suspected hypersensitivity to trial product(s) or related products
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
2. use of liraglutide or exenatide within 3 months before screening
Beskrivning

liraglutide | exenatide

Datatyp

boolean

Alias
UMLS CUI [1]
C1456408
UMLS CUI [2]
C0167117
3. severe hypoglycaemia within 1 month of screening
Beskrivning

Hypoglycemia Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
4. hypoglycaemia unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 2 months
Beskrivning

Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0011880
5. clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
Beskrivning

Haematology test abnormal | Abnormal biochemistry finding | Lipids abnormal | Urine screening abnormal | Coagulation test abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C1112712
UMLS CUI [2]
C0586680
UMLS CUI [3]
C0549634
UMLS CUI [4]
C0438142
UMLS CUI [5]
C1504379
aspartate transaminase(=ast), alanine aminotransferase (=alt), lipase, alkaline phosphatase > 2.0 times upper limit of reference range (uln)
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased | Lipase increased | Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0549475
UMLS CUI [4]
C0151849
haemoglobin < 8.0 mmol/l (male) or < 6.4 mmol/l (female), total leukocyte count <3.0 x 109/l, thrombocytes <100 x 109/l
Beskrivning

Hemoglobin measurement | Gender | Whole Blood Total Leukocyte Count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1254480
UMLS CUI [4]
C0032181
serum creatinine levels ≥ 126 μmol/l (male) or ≥ 111 μmol/l (female)
Beskrivning

Creatinine measurement, serum | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
amylase outside normal range
Beskrivning

Amylase abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C1096709
6. screening calcitonin > 50 ng/l
Beskrivning

Calcitonin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201924
7. personal history of non-familial medullary thyroid carcinoma
Beskrivning

Medullary carcinoma of thyroid

Datatyp

boolean

Alias
UMLS CUI [1]
C0238462
8. history of chronic or idiopathic acute pancreatitis suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
Beskrivning

Pancreatitis, Chronic | Idiopathic acute pancreatitis | Life threatening illness | Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Exception Diabetes Mellitus | Exception Euthyroid Goiter | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
UMLS CUI [3]
C3846017
UMLS CUI [4]
C0006826
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0025517
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0023895
UMLS CUI [11]
C0017178
UMLS CUI [12]
C0014130
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0011849
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0302859
UMLS CUI [15]
C0018939
UMLS CUI [16]
C0037274
UMLS CUI [17]
C0036916
UMLS CUI [18]
C0027765
UMLS CUI [19]
C0004936
UMLS CUI [20,1]
C0012634
UMLS CUI [20,2]
C0205164
9. proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
Beskrivning

Proliferative retinopathy | Disorder of macula of retina Proliferating | Neuropathy Severe | Autonomic neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C1514485
UMLS CUI [3,1]
C0442874
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0259749
10. any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject's safety.
Beskrivning

Disease At risk Patient safety | Condition At risk Patient safety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
11. any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
Beskrivning

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
12. female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive methods include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Sexual Abstinence | Partner had vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0036899
UMLS CUI [9]
C0420842
13. severe acute and/or chronic diseases
Beskrivning

Disease Severe | Chronic disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0008679
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT02408705

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
2. type 1 diabetes mellitus as diagnosed (including i - iii):
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Hyperglycemia | Ketonuria | Anti-islet cell antibody positive Quantity | Glutamate Decarboxylase | Protein Tyrosine Phosphatase | Zinc transporter 8 | Islet cell antibody | Fasting C-peptide level Basal Residual
Item
i. history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria ii. positive results for at least one of four islet antibodies (glutamic acid decarboxylase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies) iii. residual basal fasting c-peptide of ≥ 0.1 nmol/l
boolean
C0011854 (UMLS CUI [1])
C0020456 (UMLS CUI [2])
C0162275 (UMLS CUI [3])
C0877212 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0017785 (UMLS CUI [5])
C0085536 (UMLS CUI [6])
C4019440 (UMLS CUI [7])
C0063900 (UMLS CUI [8])
C2208720 (UMLS CUI [9,1])
C0205112 (UMLS CUI [9,2])
C1609982 (UMLS CUI [9,3])
Age
Item
3. male or female, aged 18 - 64 years (both inclusive)
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) 20.0 - 25.0 kg/m2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
5. hba1c 42 - 80 mmol/mol (6.0-9.5%)
boolean
C0474680 (UMLS CUI [1])
Insulin injection Daily | Continuous subcutaneous infusion of insulin | Insulin Dose Stable
Item
6. treated with daily insulin injections or continuous s.c. insulin infusion (csii) ≥ 1 months. stable insulin dose as judged by the investigator
boolean
C0199782 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0393124 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
1. known or suspected hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
liraglutide | exenatide
Item
2. use of liraglutide or exenatide within 3 months before screening
boolean
C1456408 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
Hypoglycemia Severe
Item
3. severe hypoglycaemia within 1 month of screening
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
4. hypoglycaemia unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 2 months
boolean
C0342317 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0011880 (UMLS CUI [2,2])
Haematology test abnormal | Abnormal biochemistry finding | Lipids abnormal | Urine screening abnormal | Coagulation test abnormal
Item
5. clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
boolean
C1112712 (UMLS CUI [1])
C0586680 (UMLS CUI [2])
C0549634 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
C1504379 (UMLS CUI [5])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Lipase increased | Alkaline phosphatase raised
Item
aspartate transaminase(=ast), alanine aminotransferase (=alt), lipase, alkaline phosphatase > 2.0 times upper limit of reference range (uln)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0549475 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Hemoglobin measurement | Gender | Whole Blood Total Leukocyte Count | Platelet Count measurement
Item
haemoglobin < 8.0 mmol/l (male) or < 6.4 mmol/l (female), total leukocyte count <3.0 x 109/l, thrombocytes <100 x 109/l
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1254480 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Creatinine measurement, serum | Gender
Item
serum creatinine levels ≥ 126 μmol/l (male) or ≥ 111 μmol/l (female)
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Amylase abnormal
Item
amylase outside normal range
boolean
C1096709 (UMLS CUI [1])
Calcitonin measurement
Item
6. screening calcitonin > 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid
Item
7. personal history of non-familial medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
Pancreatitis, Chronic | Idiopathic acute pancreatitis | Life threatening illness | Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Exception Diabetes Mellitus | Exception Euthyroid Goiter | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
8. history of chronic or idiopathic acute pancreatitis suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
C3846017 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C0035204 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0023895 (UMLS CUI [10])
C0017178 (UMLS CUI [11])
C0014130 (UMLS CUI [12])
C1705847 (UMLS CUI [13,1])
C0011849 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0302859 (UMLS CUI [14,2])
C0018939 (UMLS CUI [15])
C0037274 (UMLS CUI [16])
C0036916 (UMLS CUI [17])
C0027765 (UMLS CUI [18])
C0004936 (UMLS CUI [19])
C0012634 (UMLS CUI [20,1])
C0205164 (UMLS CUI [20,2])
Proliferative retinopathy | Disorder of macula of retina Proliferating | Neuropathy Severe | Autonomic neuropathy
Item
9. proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C1514485 (UMLS CUI [2,2])
C0442874 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0259749 (UMLS CUI [4])
Disease At risk Patient safety | Condition At risk Patient safety
Item
10. any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject's safety.
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
11. any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Sexual Abstinence | Partner had vasectomy
Item
12. female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive methods include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0015787 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
C0420842 (UMLS CUI [9])
Disease Severe | Chronic disease
Item
13. severe acute and/or chronic diseases
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
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