Informed Consent
Item
1. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
2. male subects age 18-65 years inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
3. type 1 diabetes mellitus diagnosed clinically >= 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin injection Multiple Daily | Continuous subcutaneous infusion of insulin
Item
4. treatment with multiple daily insulin injections or csii >= 12 months
boolean
C0199782 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0393124 (UMLS CUI [2])
Insulin regime Total Daily Dose
Item
5. current total daily insulin treatment <1.2 (i)u/kg/day
boolean
C0557978 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Bolus Insulin Total Daily Dose
Item
6. current total daily bolus insulin treatment <0.7 (i)u/kg/day
boolean
C1705509 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Body mass index
Item
7. body mass index 18.0-30.0 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
8. hba1c =<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)
boolean
C0474680 (UMLS CUI [1])
Insulin C-peptide measurement
Item
9. c-peptide =< 0.30 nmol/l
boolean
C0202100 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related
Item
1. known or suspected hypersensitivity to trial products 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])
Study Subject Participation Status
Item
2. previous participation in this trial. .
boolean
C2348568 (UMLS CUI [1])
Non-Prescription Drugs Investigational
Item
3. receipt of any non-marketed investigational product within 3 months
boolean
C0013231 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Haematology test abnormal | Abnormal biochemistry finding | Liver enzymes abnormal | Coagulation test abnormal
Item
4. clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
boolean
C1112712 (UMLS CUI [1])
C0586680 (UMLS CUI [2])
C0438237 (UMLS CUI [3])
C1504379 (UMLS CUI [4])
Life threatening illness | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
5. suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
boolean
C3846017 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0036916 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
C0004936 (UMLS CUI [13])
C0012634 (UMLS CUI [14])
C0205164 (UMLS CUI [15])
Deep vein thrombosis of lower limb | Deep vein thrombosis of lower limb First Degree Relative
Item
6. history of deep leg vein thrombosis or a frequent appearance of deep leg veinthrombosis in 1st degree relatives
boolean
C0340708 (UMLS CUI [1])
C0340708 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
Cardiac problem | Decompensated cardiac failure New York Heart Association Classification | Angina Pectoris | Myocardial Infarction
Item
7. cardiac problems defined as decompensated heart failure (new york heart association class iii and iv) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
boolean
C0262402 (UMLS CUI [1])
C0581377 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Lying systolic blood pressure | Lying diastolic blood pressure | Pulse Rate
Item
8. supine blood pressure at screening outside the range of 90-140 mmhg for systollic or 50-90 mmhg for diastolic . pulse outside 50 to 90 bpm.
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C0232117 (UMLS CUI [3])
ECG abnormal Screening
Item
9. clinically significant abnormal ecg at screening.
boolean
C0522055 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Proliferative retinopathy | Disorder of macula of retina Proliferating | Neuropathy Severe | Autonomic neuropathy
Item
10. proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
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
11. any disease or condition that, inthe 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])
Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
12. subject positive for hbs-ag, hcv-ab
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
HIV-1 antibody Screening test Positive | HIV-2 Antibodies Screening test Positive | HIV-1 antigen Screening test Positive
Item
13. positive result to the screening test for hiv-1 antibodies, hiv-2 antibodies, or hiv-1 antigen according to locally used diagnostic testing.
boolean
C0369497 (UMLS CUI [1,1])
C0871311 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C1255639 (UMLS CUI [2,1])
C0871311 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0369498 (UMLS CUI [3,1])
C0871311 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Drug Allergy multiple | Food Allergy multiple | Drug Allergy Severe | Food Allergy Severe | Anaphylaxis Severe
Item
14. history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
boolean
C0013182 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0016470 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0016470 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount
Item
15. subject who has donated blood or plasma in the past month or more than 500 ml within 3 months.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Operative Surgical Procedure Associated with Blood Loss Amount | Trauma Associated with Blood Loss Amount
Item
16. surgery or trauma with significant blood loss (more than 500 ml) within 3 months.
boolean
C0543467 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C3163616 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C3714660 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3163616 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones by Inhalation | Monoamine Oxidase Inhibitors | Anti-Inflammatory Agents, Non-Steroidal | Prostaglandin Antagonists | Non-selective beta-blocking agent Systemic | Growth Hormone | Vitamins | Herbal product | Thyroid Hormones
Item
17. current treatment with systemic (oral, iv, or inhaled) corticosteroids, monoamine oxidase inhibitors, nsaid, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone (last 3 months), non-routine vitamins or herbal products (last 2 weeks). yhyroid hormons are not allowed unless the use of these has been stable during the last 3 months. routine vitamins are permitted up to 48 hours prior to dosing.
boolean
C3653708 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C0026457 (UMLS CUI [5])
C0003211 (UMLS CUI [6])
C0033529 (UMLS CUI [7])
C0304515 (UMLS CUI [8,1])
C0205373 (UMLS CUI [8,2])
C0037663 (UMLS CUI [9])
C0042890 (UMLS CUI [10])
C2240391 (UMLS CUI [11])
C0040135 (UMLS CUI [12])
Alcoholic Intoxication, Chronic | Substance Use Disorders | Urine drug screen positive | Breath alcohol test positive
Item
18. significant history of alcoholism and/or drug/chemical abuse as per investigator's judgement or a positive result in the urine drug/alcohol breath test screen at the screening visit.
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0743300 (UMLS CUI [3])
C1112499 (UMLS CUI [4])
Heavy smoker
Item
19. heavy smoker
boolean
C0857118 (UMLS CUI [1])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Use of Nicotine Discontinue Unable | Use of Nicotine Discontinue Unwilling
Item
20. not able or willing to refrain from smoking and use of nicotine.
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C1524063 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C1524063 (UMLS CUI [4,1])
C0028040 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
21. recurrent severe hypoglycaemia (more than 1 severe hypoglycaemia event during the last 12 months) or hypoglycaemic unawareness.
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Mental impairment Excludes Comprehension | Language Barriers Exclude Comprehension
Item
22. subject with mental incapacity or language barriers precluding adequate understanding.
boolean
C0683322 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
Compliance behavior Lacking | Uncooperative behavior
Item
23. potentially non-compliant or uncooperative during the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0424350 (UMLS CUI [2])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
24. any condition that would interfere with trial participation or evaluation of results.
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])
Lipodystrophy Area Drug Administration | Lipodystrophy Area Doppler Ultrasound
Item
25. no relevant lipodystrophy within the area of drug administration and doppler sonography.
boolean
C0023787 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0023787 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C0162481 (UMLS CUI [2,3])