Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Insulin Glargine
Item
current treatment with insulin glargine for at least 90 days prior to screening
boolean
C0907402 (UMLS CUI [1])
Insulin Glargine Dose Stable U/day | Insulin Glargine Total Daily Dose
Item
stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable
boolean
C0907402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0907402 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
Metformin Daily Dose Stable | Metformin Maximum Tolerated Dose
Item
stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi) below or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral | Exception Metformin
Item
any use of oral antidiabetic agents (oads) (except for metformin) within 90 days prior to visit 1 (screening)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Pharmaceutical Preparation Interferes with Glucose metabolism | Exception Metformin | Exception Insulin Glargine | Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0907402 (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 Basal insulin | Insulin Mealtime | Premixed insulin | Insulin regime short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes
Item
previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0587119 (UMLS CUI [3,2])
C2069057 (UMLS CUI [4])
C0557978 (UMLS CUI [5,1])
C0443303 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0015127 (UMLS CUI [6,1])
C0009488 (UMLS CUI [6,2])
C0015127 (UMLS CUI [7,1])
C0085207 (UMLS CUI [7,2])
GLP-1 Receptor Agonist | exenatide | liraglutide
Item
previous and/or current treatment with glucagon-like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide)
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alat (alanine aminotransferase) 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 | Medical contraindication Metformin
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 (1.4 mg/dl) for females, or as allowed according to local contraindications for metformin
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of 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])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])