Informed Consent
Item
patients must sign and date an informed consent consistent with international conference on harmonisation and good clinical practice guidelines and local regulations prior to any evaluation and participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female patients with a clinical diagnosis of type 2 diabetes mellitus, at the time of informed consent, who are:
boolean
C0011860 (UMLS CUI [1])
Age
Item
70 years of age or older at informed consent or screen visit,
boolean
C0001779 (UMLS CUI [1])
Basal insulin Dose Stable | Neutral Protamine Hagedorn Insulin | insulin degludec | insulin detemir | Insulin Glargine
Item
taking stable doses of basal insulin [strictly inclusive of: insulin neutral protamine hagedorn and isophane insulin; insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0021658 (UMLS CUI [2])
C3491971 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
C0907402 (UMLS CUI [5])
Metformin Immediate Release | Metformin Extended Release | Metformin Immediate Release Absent | Metformin Extended Release Absent | Metformin Dose Stable
Item
may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)], and
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C1707968 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C1708470 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C1707968 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0025598 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
alpha-Glucosidase Inhibitors Dose Stable | alpha-Glucosidase Inhibitors Absent | Acarbose | miglitol | voglibose
Item
may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (visit 3)].
boolean
C1299007 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1299007 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0050393 (UMLS CUI [3])
C0066535 (UMLS CUI [4])
C0532578 (UMLS CUI [5])
Hemoglobin A1c measurement
Item
patients must have an glycosylated haemoglobin of 7.5% (58 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (screen).
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
patients must have a body mass index of 45 kilogram/meter squared or less at the screen visit.
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
in the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Impaired cognition Mental status Examination
Item
impaired cognitive ability as supported by the saint louis university mental status examination, additional assessment if necessary, and verified by the investigator at the screen visit.
boolean
C0338656 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C4321457 (UMLS CUI [1,3])
Depressed mood Patient Health Questionnaire
Item
depressed mood as supported by a score of 10 or more on the patient health questionnaire at the screen visit.
boolean
C0344315 (UMLS CUI [1,1])
C1879301 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus as determined by past medical records and history.
boolean
C0011854 (UMLS CUI [1])
Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome (non-st elevation myocardial infarction, stroke or transient ischemic attack within 3 months prior to screen visit.
boolean
C0948089 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
indication of liver disease determined during screen and/or run-in period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Bariatric Surgery | Gastric Bypass | Gastrointestinal Surgical Procedure | Gastric banding | Other Coding | Objective (goal) Weight loss
Item
bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or lapband) with the objective of promoting weight loss within the past two years at screen visit.
boolean
C1456587 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
C0524722 (UMLS CUI [3])
C1960832 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0018017 (UMLS CUI [6,1])
C1262477 (UMLS CUI [6,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma | Cancer treatment
Item
medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
C0920425 (UMLS CUI [4])
Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic
Item
blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
boolean
C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019054 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0014792 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])