Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral failed | Sulfonylurea | Metformin
Item
type 2 diabetes patients with first oad (sulfonylurea [su] or metformin) failure
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Insulin naive | Insulin Gestational Diabetes | Insulin regime Duration
Item
patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5mg/dl
boolean
C0201976 (UMLS CUI [1])
Body mass index
Item
bmi: 21-41 kg/m²
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
7.5%< a1c <11%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose > 7.5mmol/l
boolean
C0583513 (UMLS CUI [1])
Diet therapy | Exercise Therapeutic procedure | Antidiabetics Oral Stable | Sulfonylurea | Metformin
Item
on diet and exercise therapy and stable oad treatment (su or metformin > ½ maximal dose)for more than 1 month prior to enrolment
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
Female Sterilization | Menopausal Duration | Childbearing Potential Contraceptive methods
Item
women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
boolean
C0015787 (UMLS CUI [1])
C0025320 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Monitor blood glucose Able | Monitor blood glucose Willing
Item
able and willing to monitor blood glucose
boolean
C1820407 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1820407 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Blood Glucose Self-Monitoring Able | Blood Glucose Self-Monitoring Willing
Item
able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
boolean
C0005803 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Insulin regime Possible | Insulin injection Self Willing
Item
understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
boolean
C0557978 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperosmolar Coma
Item
acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
boolean
C0342257 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy, breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Night shift worker
Item
people who work night shifts
boolean
C0555008 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs additive | intolerance to Metformin
Item
hypersensitivity to investigational drugs or its additives, or intolerability to metformin
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0301283 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Illicit drug use Patient need for
Item
need for use of medications prohibited by the protocol during the study for treatment purpose
boolean
C0281875 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Disease Protocol Compliance Unable | Disease Difficulty with study analysis | Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Body system Disease
Item
significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
boolean
C0012634 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C0681874 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0460002 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
Substance Use Disorders
Item
drugs or alcohol abuse
boolean
C0038586 (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])