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])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Insulin Glargine
Item
current treatment with iglar (insulin glargine) for at least 90 calendar days prior to screening
boolean
C0907402 (UMLS CUI [1])
Insulin Glargine Daily Dose Stable
Item
stable daily dose of iglar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
boolean
C0907402 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Daily Dose Stable
Item
stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) below or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Weight-Loss Agents | sibutramine | orlistat | Thyroid Hormones | Adrenal Cortex Hormones
Item
anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, 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])
C0376606 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
C0076275 (UMLS CUI [5])
C0040135 (UMLS CUI [6])
C0001617 (UMLS CUI [7])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
renal impairment egfr (electronic case report form) below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology collaboration)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin at least 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])