Informed Consent
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Therapy Daily Dose Stable
Item
treatment with stable daily dose (for at least 90 days prior to screening) of: -
boolean
C0087111 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Dosage | Metformin Maximum Tolerated Dose | Sulfonylurea | Antidiabetics Oral To be stopped | Pills Insulin Releasing To be stopped | Dipeptidyl Peptidase-4 Inhibitor To be stopped | Sodium-Glucose Cotransporter 2 Inhibitor To be stopped | Colesevelam To be stopped | Bromocriptine To be stopped | Combination Product To be stopped
Item
metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, dpp4i (dipeptidyl peptidase-4 inhibitor), sglt2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1272691 (UMLS CUI [4,3])
C0994475 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C1283071 (UMLS CUI [5,3])
C1272691 (UMLS CUI [5,4])
C3537225 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
C3542461 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
C0541155 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0006230 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C1880146 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
Insulin Absent | Insulin regime short-term allowed | Insulin regime short-term Acute illness | Insulin regime Gestational Diabetes
Item
insulin-naïve. short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
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])
C0557978 (UMLS CUI [3,1])
C0443303 (UMLS CUI [3,2])
C4061114 (UMLS CUI [3,3])
C0557978 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
boolean
C0474680 (UMLS CUI [1])
Consumption Meal Main Quantity
Item
willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. the definition for 'main meal' will be according to the investigator's discretion
boolean
C0009830 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | Change of medication Affecting Body Weight | Change of medication Affecting Glucose metabolism | sibutramine | orlistat | Thyroid Hormones | CORTICOSTEROIDS FOR SYSTEMIC USE | Weight-Loss Agents
Item
anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0580105 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005910 (UMLS CUI [3,3])
C0580105 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C0074493 (UMLS CUI [5])
C0076275 (UMLS CUI [6])
C0040135 (UMLS CUI [7])
C3653708 (UMLS CUI [8])
C0376606 (UMLS CUI [9])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alt (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Hypertensive disease Treated Inadequate | Hypertensive disease Class | Systolic Pressure | Diastolic blood pressure
Item
inadequately treated high blood pressure defined as class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm hg or diastolic equal to or above 100 mm hg) in accordance with the national high blood pressure education program, 7th joint national committee1 and esh/esc 2013 guidelines2
boolean
C0020538 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0020538 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days prior to randomisation, any of the following: myocardial infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])