Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus, type 2
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
25 < bmi < 45 kg/m²
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
7,5% < hba1c < 9%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Basal insulin | insulin, isophane | Insulin, Lente | Insulin Glargine | insulin detemir | Metformin U/day
Item
treated with a basal insulin (nph, insulin zinc, insulin glargine or insulin detemir), and at least 1g metformin daily, for more than 3 months
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2])
C0021659 (UMLS CUI [3])
C0907402 (UMLS CUI [4])
C0537270 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Antidiabetics Oral
Item
treatment with oads only
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Thiazolidinediones | exenatide | Pramlintide
Item
treatment with thiazolidinediones, with exenatide or with pramlintide
boolean
C1257987 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
Insulin | Basal insulin | premixed insulin | Insulin, Short-Acting | Insulins and analogues for injection, fast-acting
Item
treatment with an insulin other than basal insulin (premix, rapid insulin, fast-acting insulin analogue)
boolean
C0021641 (UMLS CUI [1])
C0650607 (UMLS CUI [2])
C2069057 (UMLS CUI [3])
C0356365 (UMLS CUI [4])
C3653577 (UMLS CUI [5])
Proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy,
boolean
C0154830 (UMLS CUI [1])
Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Breast Feeding
Item
breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
treatment with systemic corticosteroids in the 3 months prior to study entry
boolean
C3653708 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device
Item
treatment with any investigational product in the 2 months prior to study entry
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Insulin Glulisine
Item
previous treatment with insulin glulisine
boolean
C1313386 (UMLS CUI [1])
Probability Illicit drug use Patient need for
Item
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0033204 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Diseases | Disease Major Difficulty with Protocol Compliance | Disease Major Difficulty with research results
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0332218 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
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])