Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
NPH insulin
Item
currently treated with a nph insulin for at least 3 months prior to screening
boolean
C0021658 (UMLS CUI [1])
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 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 between 7.0% and 10.0% (both inclusive). (one re-test within one week of screening visit is allowed. the last sample will 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 Quantity Daily
Item
able and willing to eat at least 2 main meals each day during the trial
boolean
C1998602 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
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 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 is allowed. the last sample will 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 µmol/l (1.5 mg/dl) for males and above or equal to 124 µmol/l (1.4 mg/dl) for females. (one re-test within one week of screening visit is allowed. the last sample will 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 above or equal to 180 mmhg and/or diastolic blood pressure above 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
Item
previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
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])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])