Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent | Insulin regime short-term allowed | Treatment Hospitalization allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subjects (allowed are: previous short term insulin treatment no longer than or equal to 14 days in total; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0019993 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Metformin | Combined Modality Therapy | Antidiabetics Oral | Pills Releasing Insulin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Thiazolidinediones | Pharmaceutical Preparations Dose unchanged
Item
current treatment: metformin alone or metformin in any combination of 1 or 2 additional oads (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (tzds) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0994475 (UMLS CUI [4,1])
C1283071 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
C0013227 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0442739 (UMLS CUI [10,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) 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 measurement of plasma glucose
boolean
C0525058 (UMLS CUI [1])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
GLP-1 Receptor Agonist
Item
treatment with glp-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
boolean
C2917359 (UMLS CUI [1])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe 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])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
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])
Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habit Variation
Item
anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C1266864 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])