Diabetes Mellitus, Non-Insulin-Dependent | Ketosis | insulin, isophane | Insulin Mealtime | Therapeutic procedure Stable
Item
subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with nph insulin(once or twice daily)and mealtime insulin for at least 3 months.
boolean
C0011860 (UMLS CUI [1])
C0022638 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Glycosylated hemoglobin A
Item
hba1c values smaller/equal 8.0%(measured at screening visit, visit 1).
boolean
C0019018 (UMLS CUI [1])
Blood Glucose Self-Monitoring | Blood glucose meter
Item
ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home.
boolean
C0005803 (UMLS CUI [1])
C0472226 (UMLS CUI [2])
Diabetes | Diabetes Mellitus, Non-Insulin-Dependent
Item
all forms of diabetes other than type 2 diabetes mellitus.
boolean
C0011847 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Oral hypoglycemic | Insulin | insulin, isophane | Insulin Mealtime | Metformin | Dosage Stable
Item
oral antidiabetic drugs(oads)and/or insulins other than nph and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study).
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5])
C0178602 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
Pregnancy Urine pregnancy test
Item
pregnant(as determined by urine pregnancy test at visit 1)or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Lack | Hormonal Contraceptives, Systemic | Pregnancy, Planned
Item
women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
Illicit drug use Study Protocol Patient need for | systemic steroids
Item
likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids).
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C2825233 (UMLS CUI [2])
Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Chemical Structure Similar
Item
history of hypersensitivity to the study medication or to drugs with similar chemical structures.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Investigational New Drugs
Item
treatment with any investigational drugs in the last month before study entry.
boolean
C0013230 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Operative Surgical Procedures Patient need for
Item
diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study.
boolean
C0543467 (UMLS CUI [1,1])
C0011884 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2])
C0042903 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Cardiovascular Diseases Relevant Clinical | Gastrointestinal Diseases | Liver diseases | nervous system disorder | Endocrine System Diseases | Hematological Disease | Systemic disease Major Interferes with Study Protocol | Systemic disease Major Interferes with research results
Item
clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0442893 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C2348563 (UMLS CUI [7,4])
C0442893 (UMLS CUI [8,1])
C0205164 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Hepatic Insufficiency | Renal Insufficiency
Item
known impaired hepatic or renal function.
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [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])