Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin | Exception Mealtime Insulin | insulin detemir times per day | Insulin Glargine times per day | NPH insulin times per day | Combined Modality Therapy | Antidiabetics Oral Dose Stable | Metformin | Pills Releasing Insulin | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors | pioglitazone | Dipeptidyl Peptidase 4 Inhibitors
Item
current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (od), insulin glargine od or neutral protamine hagedorn (nph) insulin od/twice daily (bid) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of oad(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase iv (dpp-iv) inhibitor in any approved (according to label) dose or combination. stable oad doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
boolean
C0650607 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C0537270 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4,1])
C0439511 (UMLS CUI [4,2])
C0021658 (UMLS CUI [5,1])
C0439511 (UMLS CUI [5,2])
C0009429 (UMLS CUI [6])
C0935929 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C0025598 (UMLS CUI [8])
C0994475 (UMLS CUI [9,1])
C1283071 (UMLS CUI [9,2])
C0021641 (UMLS CUI [9,3])
C0038766 (UMLS CUI [10])
C2266929 (UMLS CUI [11])
C1299007 (UMLS CUI [12])
C0071097 (UMLS CUI [13])
C2917254 (UMLS CUI [14])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Plasma Glucose Measurement Self
Item
ability and willingness to adhere to the protocol including self-measured plasma glucose (smpg) according to the protocol
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
rosiglitazone
Item
treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
boolean
C0289313 (UMLS CUI [1])
GLP-1 Receptor Agonist
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
boolean
C2917359 (UMLS CUI [1])
Recurrent severe hypoglycemia | Hypoglycaemic episode Quantity | Loss of hypoglycemic warning
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician)
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0342317 (UMLS CUI [3])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Investigational New Drugs
Item
the receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
boolean
C0013230 (UMLS CUI [1])