Age | Informed Consent
Item
age: 18-64 years (both inclusive) at the time of signing the informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
for subjects with type 2 diabetes:
boolean
C0681850 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female subjects diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise | Metformin Dosage unchanged
Item
treated with diet and exercise and/or metformin monotherapy. metformin dose should be unchanged in a period of 30 days prior to screening
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Body mass index
Item
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 6.5-9.0 % (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Healthy Control | Glucose Injection
Item
for healthy control group for graded glucose infusion:
boolean
C2986479 (UMLS CUI [1])
C4257321 (UMLS CUI [2])
Healthy Volunteers
Item
healthy male and female subjects
boolean
C1708335 (UMLS CUI [1])
Body mass index
Item
bmi between 24.0-32.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c less than 6.5 %
boolean
C0474680 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods | Contraceptive implant | Contraceptive injection | Oral Contraceptives Combined | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or 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])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1657106 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C0009905 (UMLS CUI [8,1])
C0205195 (UMLS CUI [8,2])
C0021900 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
C0420842 (UMLS CUI [11])
Medical History Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease
Item
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2])
C0178784 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0080276 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
Prescription Drugs Interfere with Research results Pharmacokinetic | Prescription Drugs Interfere with Research results Pharmacodynamic | Non-Prescription Drugs Interfere with Research results Pharmacokinetic | Non-Prescription Drugs Interfere with Research results Pharmacodynamic | CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | Non-selective beta-blocking agent | Thyroid Hormones
Item
use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
boolean
C0304227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,4])
C0304227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0851347 (UMLS CUI [2,4])
C0013231 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0031328 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0851347 (UMLS CUI [4,4])
C3653708 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C3653708 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
C0304515 (UMLS CUI [7])
C0040135 (UMLS CUI [8])
Substance Use Disorders | Urine drug screening Positive
Item
history of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
boolean
C0038586 (UMLS CUI [1])
C0202274 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Alcohol abuse | Alcohol breath testing Positive
Item
history of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
boolean
C0085762 (UMLS CUI [1])
C0202306 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Tobacco use Number of cigarettes per day
Item
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Chewing Gum Discontinue Unable | Nicotine Transdermal Patch Discontinue Unable | Nicotine Chewing Gum Discontinue Unwilling | Nicotine Transdermal Patch Discontinue Unwilling
Item
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0599654 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0358855 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C0599654 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0358855 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])