Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Poor glycemic control | Glucohemoglobin measurement
Item
have inadequate overall glycemic control (hemoglobin a1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to visit 1
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Use of
Item
have used:
boolean
C1524063 (UMLS CUI [1])
Oral hypoglycemic Single | Oral hypoglycemics multiple | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | alpha-Glucosidase Inhibitors | Acarbose | miglitol
Item
single or multiple oams for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
boolean
C0359086 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0065880 (UMLS CUI [5])
C0246689 (UMLS CUI [6])
C0903898 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0050393 (UMLS CUI [9])
C0066535 (UMLS CUI [10])
Insulin Once daily | Insulin Twice a day
Item
insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
boolean
C0021641 (UMLS CUI [1,1])
C0556983 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0585361 (UMLS CUI [2,2])
Combination Pharmaceutical Preparations enumerated
Item
a combination of the above.
boolean
C0205195 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1707927 (UMLS CUI [1,3])
Age
Item
are greater than or equal to 21 and less than 80 years of age
boolean
C0001779 (UMLS CUI [1])
Capability | Willing
Item
as determined by the investigator, are capable and willing to:
boolean
C2698977 (UMLS CUI [1])
C0600109 (UMLS CUI [2])
Compliance with prescribed diet | Compliance behavior to prescribed medication
Item
comply with their prescribed diet and medication regimen,
boolean
C4039442 (UMLS CUI [1])
C2585769 (UMLS CUI [2])
Blood Glucose Self-Monitoring
Item
perform self blood glucose monitoring,
boolean
C0005803 (UMLS CUI [1])
Study Protocol Subject Diary Use of
Item
use the patient diary as required for this protocol,
boolean
C2348563 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
Inpatient Assessment 24 Hours | Participation Assessment Two
Item
participate in two 24 hour inpatient assessments
boolean
C0021562 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0205448 (UMLS CUI [2,3])
Thiazolidinediones | pioglitazone | rosiglitazone
Item
have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
boolean
C1257987 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0289313 (UMLS CUI [3])
Meglitinide | Sulfonylurea
Item
are currently treated with a meglitinide without sulfonylurea
boolean
C0065880 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
Hypersensitivity Insulin Lispro Mix 25 75 | Intolerance to Insulin Lispro Mix 25 75 | Hypersensitivity Insulin Glargine | Intolerance to Insulin Glargine | Hypersensitivity Metformin | Intolerance to Metformin
Item
have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
boolean
C0020517 (UMLS CUI [1,1])
C0977811 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0977811 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0907402 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0025598 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0025598 (UMLS CUI [6,2])
plasma creatinine measurement | Gender | Metformin | Oral hypoglycemics
Item
have plasma creatinine greater than or equal to 1.5 mg/dl (for males) or greater than or equal to 1.4 mg/dl (for females) for patients who will be treated with metformin or; greater than 2 mg/dl for patients treated with other oams, as determined by a local laboratory
boolean
C1278055 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
Systemic Glucocorticoids chronic | Preparations topical | Inhaled drugs
Item
have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to visit 1
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0556393 (UMLS CUI [3])