Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Age
Item
male or female equal to or above 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
boolean
C0474680 (UMLS CUI [1])
Metformin Stable U/day | Metformin Maximum Tolerated Dose | Pioglitazone Dosage | Pioglitazone Absent
Item
stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0071097 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) below or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics | Exception Metformin | Exception Pioglitazone | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0071097 (UMLS CUI [3,2])
C0580105 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C3653708 (UMLS CUI [5])
Insulin regime | Exception Therapeutic procedure short-term Comorbidity | Exception Therapeutic procedure short-term Gestational Diabetes
Item
previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0085207 (UMLS CUI [3,4])
GLP-1 Receptor Agonist | Sulfonylurea | Glinide | Dipeptidyl Peptidase-4 Inhibitor | SGLT2 Inhibitor
Item
treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit
boolean
C2917359 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C2266929 (UMLS CUI [3])
C3537225 (UMLS CUI [4])
C3273807 (UMLS CUI [5])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Macular retinal edema Treatment required for
Item
proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0271051 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])