Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement Maximum
Item
hba1c maximum 10 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Therapy Oral Basal | Insulin Mealtime Absent | Insulin Glargine times per day | Dose unchanged | Combined Modality Therapy | Antidiabetics Oral Stable | Metformin | Pills Releasing Insulin | pioglitazone | sitagliptin | alpha-Glucosidase Inhibitors
Item
current treatment with basal-oral therapy (bot) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to visit 1) oad (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
boolean
C0087111 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205112 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0907402 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
C0178602 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0009429 (UMLS CUI [5])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0025598 (UMLS CUI [7])
C0994475 (UMLS CUI [8,1])
C1283071 (UMLS CUI [8,2])
C0021641 (UMLS CUI [8,3])
C0071097 (UMLS CUI [9])
C1565750 (UMLS CUI [10])
C1299007 (UMLS CUI [11])
exenatide | liraglutide | Thiazolidinediones | Exception Pioglitazone
Item
use within the last three months prior to visit 1 of: exenatide, liraglutide or thiazoledinediones (tzds) other than pioglitazone
boolean
C0167117 (UMLS CUI [1])
C1456408 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0071097 (UMLS CUI [4,2])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease (cvd) defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to visit 1
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous six 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])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
StudyStudy Subject Participation Status | Investigational New Drugs Started
Item
previous participation in this trial. participation is defined as started on trial medication. rescreening of screening failures is allowed only once within the limits of the recruitment period
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1272689 (UMLS CUI [2,2])
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])