Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Antidiabetics Oral naive | Antidiabetics Oral Irregular allowed
Item
oral anti-diabetic drug (oad) naïve (unsystematic oad treatment 6 months prior to this trial is allowed)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205271 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
Insulin naive | Insulin regime short-term allowed
Item
insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Hypoglycemic Agents naive
Item
lipid-lowing agent naïve
boolean
C0020616 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c: 6.5-8.5%
boolean
C0202054 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose: 6.1-13.0 mmol/l (110-234 mg/dl)
boolean
C0202045 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): 20-35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Plasma Glucose Self Monitoring Able | Plasma Glucose Self Monitoring Willing
Item
be able and willing to perform self-monitored plasma glucose (smpg)
boolean
C0202042 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0202042 (UMLS CUI [2,1])
C0588436 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Meal Main Quantity per day
Item
be able and willing to eat 3 main meals per day
boolean
C1998602 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
Subgroup Clinical Trial | Intravenous Glucose Tolerance Test Completion
Item
only applicable to subjects who will participate in the subgroup study: be able and willing to perform and complete ivgtt (intravenous glucose tolerance test) at additional visits
boolean
C1515021 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0021911 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Hypersensitivity repaglinide | Hypersensitivity Suspected repaglinide | Gliclazide allergy | Hypersensitivity Suspected Gliclazide | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related | Hypersensitivity Sulfonamides | Hypersensitivity Suspected Sulfonamides | Hypersensitivity Sulfonylurea | Hypersensitivity Suspected Sulfonylurea | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Suspected Investigational New Drugs Excipient
Item
known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (sus)), or any of the excipients in the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0246689 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0246689 (UMLS CUI [2,3])
C0571641 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0017631 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C0020517 (UMLS CUI [7,1])
C0038760 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C0038760 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0038766 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0750491 (UMLS CUI [10,2])
C0038766 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C0013230 (UMLS CUI [11,2])
C0015237 (UMLS CUI [11,3])
C0020517 (UMLS CUI [12,1])
C0750491 (UMLS CUI [12,2])
C0013230 (UMLS CUI [12,3])
C0015237 (UMLS CUI [12,4])
Study Subject Participation Status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
participation in a study of another investigational drug within 1 month prior to study start
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])