Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin Maximum Tolerated Dose U/day | Sulfonylurea Maximum Tolerated Dose U/day | Glimepiride U/day
Item
treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other su) for at least 3 months prior to the screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0061323 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Hemoglobin A1c measurement
Item
7.0 < hba1c < 11 %
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting serum c-peptide > 0.33 nmol/l
boolean
C2208720 (UMLS CUI [1])
Body mass index
Item
bmi < 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring Willing
Item
patients who is willing to monitor bg using smbg
boolean
C0005803 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Liver disease | Alanine aminotransferase increased
Item
clinical evidence of active liver disease, or serum alt 3 times the upper limit of the normal range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum | Gender
Item
serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Unstable | Retinal Disease Rapidly progressive | Light Coagulation Required | Operative Surgical Procedures Required | Optic fundus observation Recommended
Item
active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0035309 (UMLS CUI [5,1])
C1838681 (UMLS CUI [5,2])
C0023694 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0543467 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0423377 (UMLS CUI [8,1])
C0034866 (UMLS CUI [8,2])
Substance Use Disorders
Item
history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or not using contraceptive in childbearing aged women
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Breast Feeding
Item
breast feeding women
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])
Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones | Medicinal Herbs | Exception Metformin | Exception Sulfonylurea
Item
treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C0025125 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
Study Subject Participation Status | Considerations 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])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])