Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Therapy Stable Diabetes | Diet therapy | Exercise | Metformin Daily Dose | Metformin Maximum Tolerated Dose | Metformin Absent
Item
subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0011847 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C2348070 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi: 25.0 - 40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
simultaneous participation in any other clinical trial of an investigational medicinal product
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implant | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Male sterilization
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: 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 device), or sexual abstinence or vasectomised partner. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
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])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C0009907 (UMLS CUI [11])
C2985296 (UMLS CUI [12,1])
C0086466 (UMLS CUI [12,2])
C2985296 (UMLS CUI [13,1])
C0021102 (UMLS CUI [13,2])
C4293370 (UMLS CUI [14])
C0004764 (UMLS CUI [15])
C0221829 (UMLS CUI [16])
C0493327 (UMLS CUI [17])
C3843415 (UMLS CUI [18])
C0015787 (UMLS CUI [19])
C0024559 (UMLS CUI [20])
Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria | Exception Insulin regime short-term Acute illness
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C4061114 (UMLS CUI [4,4])
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | orlistat | Thyroid Hormones | Adrenal Cortex Hormones
Item
anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0076275 (UMLS CUI [3])
C0040135 (UMLS CUI [4])
C0001617 (UMLS CUI [5])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Family history Multiple Endocrine Neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma | Medullary carcinoma of thyroid
Item
family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc)
boolean
C0241889 (UMLS CUI [1,1])
C0027662 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
C0238462 (UMLS CUI [4])
Renal Insufficiency Severe | Renal Insufficiency Moderate | Estimated Glomerular Filtration Rate
Item
severe to moderate renal impairment defined as gfr, estimated below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days before screening any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])
Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
currently planned coronary, carotid or peripheral artery revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3495793 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1096418 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
New York Heart Association Classification
Item
patients presently classified as being in new york heart association (nyha) class iii or iv
boolean
C1275491 (UMLS CUI [1])