Eligibility Diabetes Mellitus, Type 2 NCT00191464

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes (world health organization [who] classification
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic | Metformin | Second generation sulfonylurea | Glyburide | Glipizide | Gliclazide | glimepiride | Administration of insulin Quantity per day | Subcutaneous injection of insulin
Item
have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate.
boolean
C0359086 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1300198 (UMLS CUI [3])
C0017628 (UMLS CUI [4])
C0017642 (UMLS CUI [5])
C0017631 (UMLS CUI [6])
C0061323 (UMLS CUI [7])
C0199782 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0439505 (UMLS CUI [8,3])
C0586328 (UMLS CUI [9])
Glycosylated hemoglobin A
Item
have a hemoglobin a1c between 6.5% and 11%, inclusive, according to the central laboratory at visit 1.
boolean
C0019018 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
have clinically acceptable ldl-c, in the investigator's opinion, at visit 1.
boolean
C0202117 (UMLS CUI [1])
Insulin Injection pen Use Willing | Compliance with prescribed diet | Exercise Compliance | Medication regimen Compliance | Blood Glucose Self-Monitoring | Subject Diary
Item
as determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol.
boolean
C0021641 (UMLS CUI [1,1])
C3273588 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C4039442 (UMLS CUI [2])
C0015259 (UMLS CUI [3,1])
C3714738 (UMLS CUI [3,2])
C0237125 (UMLS CUI [4,1])
C3714738 (UMLS CUI [4,2])
C0005803 (UMLS CUI [5])
C3890583 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Metformin | Hypersensitivity Metformin hydrochloride | Hypersensitivity Insulin Lispro | Hypersensitivity Insulin Glargine | Hypersensitivity Excipients Substances named
Item
have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro mm, insulin lispro lm, or insulin glargine, or excipients contained in these products.
boolean
C0020517 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0770893 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0293359 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
C0439861 (UMLS CUI [5,3])
C0027365 (UMLS CUI [5,4])
Metabolic acidosis | Acidosis, Lactic
Item
have known metabolic or lactic acidosis.
boolean
C0220981 (UMLS CUI [1])
C0001125 (UMLS CUI [2])
Kidney Transplantation | Dialysis procedure | Creatinine measurement, serum | Gender
Item
have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/l (1.5 mg/dl) for males and greater than or equal to 110 micromol/l (1.2 mg/dl) for females.
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Heart Diseases | New York Heart Association Classification
Item
have cardiac disease with functional status that is class iii or iv
boolean
C0018799 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Liver disease Sign or Symptom | Acute hepatitis | Hepatitis, Chronic | Alanine aminotransferase measurement
Item
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (alt) greater than three times the upper limit of the reference range as defined by the central laboratory.
boolean
C0023895 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0201836 (UMLS CUI [4])

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