Non-Insulin-Dependent Diabetes Mellitus Disease length | Lantus | Sulfonylurea
Item
type 2 diabetes mellitus, treated with lantus±su; ≥5-year after diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0876064 (UMLS CUI [2])
C3536898 (UMLS CUI [3])
Age
Item
aged 20-75 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c ≥7.0%-≤10.0%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose ≤180 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Lantus Stable status
Item
stable treatment (±20%) with lantus for 3 months or more prior to screening.
boolean
C0876064 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Sulfonylurea Dose Stable
Item
sulfonylurea dose stable for 3 months or more prior to screening
boolean
C3536898 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Lixisenatide
Item
hypersensitivity to lixisenatide
boolean
C0020517 (UMLS CUI [1,1])
C2973895 (UMLS CUI [1,2])
Blood Glucose Uncontrolled Severe
Item
severely uncontrolled glycemic situation
boolean
C0005802 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Pancreatitis Unexplained | Pancreatitis, Chronic | Pancreatectomy | Operation on stomach | Inflammatory Bowel Disease
Item
history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
boolean
C0030305 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0149521 (UMLS CUI [2])
C0030279 (UMLS CUI [3])
C0192398 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
Metabolic acidosis | Diabetic Ketoacidosis
Item
history of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
boolean
C0220981 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Heart failure Requirement Hospitalization | Substance Use Disorders
Item
history within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0019993 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4])
Uncontrolled hypertension | Poor hypertension control | Systolic blood pressure at rest | Diastolic blood pressure at rest
Item
uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmhg or diastolic blood pressure >95 mmhg
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
C2039694 (UMLS CUI [3])
C2183311 (UMLS CUI [4])
Serum amylase raised | Serum lipase raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum alkaline phosphatase raised
Item
amylase and/or lipase >3 times or aspartate aminotransferase (ast), alanine aminotransferase (alt) or alkaline phosphatase (alp) >2 times the upper limit of the normal laboratory range
boolean
C0476327 (UMLS CUI [1])
C3670924 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C1314665 (UMLS CUI [5])
Kidney Failure, Chronic | Dialysis | Gastrointestinal Diseases
Item
end-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
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])