Non-Insulin-Dependent Diabetes Mellitus disease length
Item
subjects with type 2 dm diagnosed for at least 3 months but no longer than 10 years before screening;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
- bmi ≤ 40 kg/m²;
boolean
C1305855 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
a negative pregnancy test for all females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
metabolic; complications | Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma
Item
a history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
boolean
C1393263 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Antidiabetics Oral | Sulfonylurea | Metformin | Thiazolidinediones
Item
current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Concomitant Therapy
Item
concomitant treatment prohibited during the study period;
boolean
C1707479 (UMLS CUI [1])
Antidiabetics Oral | Investigational New Drugs
Item
any oral anti-diabetic drugs other than study medication
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Insulin regime Acute metabolic decompensation | Insulin regime Sepsis
Item
any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
boolean
C0557978 (UMLS CUI [1,1])
C2673978 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0243026 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE Intermittent | inhaled steroids Dose Large
Item
intermittent use of systemic corticosteroids or large dose of inhaled steroids
boolean
C3653708 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0549177 (UMLS CUI [2,3])
Kidney Disease | Creatinine measurement, serum | Gender | Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
subjects with clinically significant renal (serum creatinine level >1.5 mg/dl in male and >1.4 mg/dl in female) or hepatic disease (alanine aminotransferase (alt) and aspartate aminotransferase (ast) >2x upper limit of normal (uln));
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
Cardiovascular Disease Severe | Heart failure | Myocardial Infarction | Cerebrovascular accident
Item
subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Laboratory test result abnormal | Medical condition Affecting Protocol Compliance | Medical condition Affecting research results
Item
clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
boolean
C0438215 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
history of drug or alcohol abuse;
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity glimepiride | Metformin allergy | Night shift worker
Item
subjects with known hypersensitivity to glimepirides, or metformin; night-shift workers;
boolean
C0020517 (UMLS CUI [1,1])
C0061323 (UMLS CUI [1,2])
C0571648 (UMLS CUI [2])
C0555008 (UMLS CUI [3])
Investigational New Drugs
Item
treatment with any investigational product in the last 3 months before study entry;
boolean
C0013230 (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])