Run-in Period
Item
run-in phase:
boolean
C3274438 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
t2dm
boolean
C0011860 (UMLS CUI [1])
Basal insulin | Insulin Glargine | NPH insulin | Detemir
Item
treated for at least 3 months with a basal insulin (insulin glargine, nph, detemir)
boolean
C0650607 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
Antidiabetics Oral | Glucohemoglobin measurement | Insulin naive
Item
+/- oral antidiabetic drugs (oads) with an hba1c >7.0% or insulin naive (2-3 oads) with an hba1c >=7.8% (historic hba1c result up to 3 months of screening is acceptable)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
Randomization Treatment Phase
Item
randomized treatment phase:
boolean
C0034656 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
Run-in Period Completed
Item
completed run-in phase
boolean
C3274438 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Glucohemoglobin measurement | Nocturnal hypoglycemia Episode Quantity | Blood glucose measurement | Fasting Glucose measurement Quantity | Insulin Glargine
Item
hba1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (bg <4.0 mmol/l) or >= 2 measurements of fg <=6.0 mmol/l within the previous week patients who completed the run-in phase with hba1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
boolean
C0202054 (UMLS CUI [1])
C0342315 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0392201 (UMLS CUI [3])
C0202045 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0907402 (UMLS CUI [5])
Oral food intake Absent Before Lunch
Item
no food intake before lunch (noon)
boolean
C0518037 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1550741 (UMLS CUI [1,3])
Diet Intake Unstable | Diet therapy Change
Item
unstable diet intake or significant changes to current diet regimen
boolean
C0012155 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
Night shift worker
Item
nightshift worker
boolean
C0555008 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin injection Unwilling | Blood Glucose Self-Monitoring Unwilling
Item
subjects unwilling to inject insulin or perform self-monitoring blood glucose
boolean
C0199782 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Substance Use Disorders
Item
pregnant, alcohol or drug abuse
boolean
C0032961 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Malignant Neoplasms Study Subject Participation Status Inappropriate | Disease Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate
Item
active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
boolean
C0006826 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
Laboratory test findings Clinical Significance Exclude Completion of clinical trial
Item
any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
boolean
C0587081 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
Hypersensitivity Investigational New Drugs
Item
known allergies to study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status Aspect Additional
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 [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])