Age | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Controlled Inadequate | Insulin Absent | Basal insulin
Item
patients ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C0021641 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0650607 (UMLS CUI [5])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c at screening visit:
boolean
C0019018 (UMLS CUI [1])
Basal insulin
Item
<7.0% or >10.0% for patients taking basal insulin.
boolean
C0650607 (UMLS CUI [1])
Insulin Therapy naive
Item
<7.5% or >11.0% for insulin-naïve patients.
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent disease length
Item
history of type 2 diabetes mellitus for less than 1 year before screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Dose Unstable
Item
patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
boolean
C0650607 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Diabetes Therapy Dose Change | Initiation Pharmaceutical Preparations Glucose Lowering
Item
change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
boolean
C3274787 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1704686 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0017725 (UMLS CUI [2,3])
C2003888 (UMLS CUI [2,4])
bolus infusion Insulin chronic | bolus infusion Insulin Combined Basal insulin | Insulin Therapy naive | Acute illness | Operative Surgical Procedures
Item
chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, eg, premix insulin; for insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
boolean
C1511237 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1511237 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C0650607 (UMLS CUI [2,4])
C0021641 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
C4061114 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
Cognition Disorders | Dementia | Mini-mental state examination | nervous system disorder Affecting Compliance behavior
Item
cognitive disorder and dementia assessed clinically and by mini-mental state examination (mmse) score <24, or any neurologic disorder that will likely affect the patient's ability to follow the study procedure. the patient will be eligible despite an mmse score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
boolean
C0009241 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0451306 (UMLS CUI [3])
C0027765 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
Kidney Failure, Chronic | Estimated Glomerular Filtration Rate Modification of diet in renal disease formula
Item
patients who have end-stage renal disease (<15 ml/min/1.73m^2, per estimated glomerular filtration rate [egfr] measurement by modification of diet in renal disease [mdrd]).
boolean
C0022661 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C3839656 (UMLS CUI [2,2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])