Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 12 months prior to visit 1 (screening)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Analogue
Item
currently treated with a basal insulin analogue for at least 3 months prior to visit 1 (screening)
boolean
C0650607 (UMLS CUI [1,1])
C0243071 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral | Antidiabetics Oral Absent
Item
stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment. the metformin treatment must have been stable for at least 2 months prior to visit 1 (screening)
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Hemoglobin A1c measurement
Item
hba1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Meal Main Quantity each day
Item
able and willing to eat at least 2 main meals each day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
Protocol Compliance | Plasma Glucose Measurement Self | Injection therapy | Titration Self
Item
able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0444472 (UMLS CUI [3])
C0162621 (UMLS CUI [4,1])
C0036588 (UMLS CUI [4,2])
Experience Plasma Glucose Measurement Self
Item
experience in performing self measured plasma glucose (smpg)
boolean
C0596545 (UMLS CUI [1,1])
C0202042 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
Thiazolidinediones | GLP-1 Receptor Agonist | Pramlintide
Item
treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to visit 1 (screening)
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired kidney function with serum creatinine above or equal to 133 micromol/l (1.5 mg/dl) for males and above or equal to 124 micromol/l (1.4 mg/dl) for females (one re-test within one week of screening visit was allowed. the last sample was to be conclusive)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Cardiac problem | Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmhg and/or diastolic blood pressure higher or equal to 100 mmhg)
boolean
C0262402 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Premixed insulin | Premixed insulin Analogue | Premixed Human Insulin | Bolus Insulin
Item
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (visit 1)
boolean
C2069057 (UMLS CUI [1])
C2069057 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C2069057 (UMLS CUI [3,1])
C0795635 (UMLS CUI [3,2])
C0021641 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])