Age
Item
aged 18-79 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Controlled Inadequate | Insulin Glargine | Metformin | Combined Modality Therapy
Item
type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin
boolean
C0011860 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0907402 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed of type 2 diabetes for at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Glargine Dose Stable | Metformin Dose Stable
Item
treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
boolean
C0907402 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Glucohemoglobin measurement
Item
hba1c > 7.0 and </= 10.0% at screening
boolean
C0202054 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes patients
boolean
C0011854 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery
Item
myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
clinical evidence of active liver disease, or serum alt or ast 3 times the upper limit of the normal (uln) range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
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
Item
active proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Antidiabetics | Exception Insulin Glargine | Exception Metformin
Item
any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Gastrointestinal Diseases Associated with Deranged intestinal motility | Gastrointestinal Diseases Associated with Nutrient absorption altered | Gastroparesis | Malabsorption Syndrome | Chronic diarrhea | Intestinal Diseases | Inflammatory Bowel Diseases | Partial bowel obstruction | Hernia Large
Item
gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
boolean
C0017178 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0232673 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C1961155 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0152020 (UMLS CUI [3])
C0024523 (UMLS CUI [4])
C0401151 (UMLS CUI [5])
C0021831 (UMLS CUI [6])
C0021390 (UMLS CUI [7])
C1328480 (UMLS CUI [8])
C0019270 (UMLS CUI [9,1])
C0549177 (UMLS CUI [9,2])
Galactosemia
Item
galactose intolerance
boolean
C0016952 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Birth | Abortion | Breast Feeding
Item
delivery, abortion, or lactation within less than three cycles before the start of treatment
boolean
C0005615 (UMLS CUI [1])
C0156543 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Barrier Contraception
Item
no use of contraceptive in childbearing aged. women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient
Item
hypersensitivity to the active substances or any of gradient of the study drug ingredients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
Pharmaceutical Preparations Affecting Blood glucose level | Adrenal Cortex Hormones Affecting Blood glucose level | Herbal medicine Affecting Blood glucose level
Item
treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0428554 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0428554 (UMLS CUI [2,3])
C2240391 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0428554 (UMLS CUI [3,3])
Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial
Item
any disease or condition that in the opinion of the investigator may interfere with completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])