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])
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])