Non-Insulin-Dependent Diabetes Mellitus Poorly controlled | Hypoglycemic Agents | Exception Insulin | Exception Injectables | Basal insulin Appropriate
Item
patients with t2dm inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the investigator/treating physicians has decided that basal insulin is appropriate.
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0020616 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0086466 (UMLS CUI [4,2])
C0650607 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycated hemoglobin a1c (hba1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
boolean
C0474680 (UMLS CUI [1])
Age
Item
age <18 years at the time of screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) >40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
diabetes other than t2dm.
boolean
C0011849 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
history of t2dm for less than 1 year before screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hypoglycemic Agents
Item
less than 6 months anti-hyperglycemic treatment before screening.
boolean
C0020616 (UMLS CUI [1])
Hypoglycemic Agents New | Weight-Loss Agents
Item
initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
boolean
C0020616 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2])
GLP-1 Receptor Agonist
Item
previous treatment with glucagon like peptide-1 (glp-1) agonist.
boolean
C2917359 (UMLS CUI [1])
Hypoglycemic Agents | Exception Insulin | Exception Sulfonylurea | Exception Glinide
Item
patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2266929 (UMLS CUI [4,2])
Insulin use | Exception Acute illness | Exception Operative Surgical Procedures
Item
current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
boolean
C0240016 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C4061114 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Medical contraindication Insulin Glargine | Medical contraindication Lantus
Item
any contraindication to insulin glargine (lantus) according to the national product labeling or any excipients.
boolean
C1301624 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0876064 (UMLS CUI [2,2])
Medical contraindication Hypoglycemic Agents | Exception Insulin
Item
any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective national product labeling.
boolean
C1301624 (UMLS CUI [1,1])
C0020616 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Timepoint Eye examination Last
Item
latest eye examination by an ophthalmologist >12 months prior to inclusion.
boolean
C2348792 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Episode Quantity Hypoglycemia Severe | Seizure | Coma | Requires Assistance
Item
more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0036572 (UMLS CUI [2])
C0009421 (UMLS CUI [3])
C1269765 (UMLS CUI [4])
Proliferative diabetic retinopathy Unstable | Diabetic Retinopathy Progressive Rapid | Macular edema Treatment required for | Laser Surgery | Operative Surgical Procedures | Injectables
Item
unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
boolean
C0154830 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0011884 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0456962 (UMLS CUI [2,3])
C0271051 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0023087 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0086466 (UMLS CUI [6])
Study Subject Participation Status | Considerations Incomplete
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])
C0518609 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])