Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed as having type 2 diabetes mellitus, as defined by the world health organization
boolean
C0011860 (UMLS CUI [1])
Metformin | Insulin Once daily | Hypoglycemic Agents Quantity
Item
are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry
boolean
C0025598 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0556983 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Breast Feeding Urine pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Planned Pregnancy Unwilling | Contraceptive methods
Item
female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study
boolean
C0006147 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4])
Glucohemoglobin measurement
Item
hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1
boolean
C0202054 (UMLS CUI [1])
Informed Consent
Item
have given informed consent to participate in the study in accordance with local regulations
boolean
C0021430 (UMLS CUI [1])
Research Personnel Affiliated Clinical Trial | Research Personnel Family Affiliated Clinical Trial
Item
are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
boolean
C0035173 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0035173 (UMLS CUI [2,1])
C0015576 (UMLS CUI [2,2])
C1510826 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Drugs, Non-Prescription
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013231 (UMLS CUI [1])
clinical depression | Central Nervous System Stimulants | Antidepressive Agents | Antipsychotic Agents | Anti-Anxiety Agents
Item
have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry
boolean
C2362914 (UMLS CUI [1])
C0002763 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
Hypersensitivity Insulin Lispro Mixture Low | Hypersensitivity Insulin Glargine | Hypersensitivity Metformin hydrochloride | Hypersensitivity Excipients
Item
have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products
boolean
C0020517 (UMLS CUI [1,1])
C0293359 (UMLS CUI [1,2])
C0439962 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0770893 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
Hypersensitivity Metformin hydrochloride | Medical contraindication Metformin hydrochloride
Item
have known hypersensitivity or contraindication to metformin hydrochloride
boolean
C0020517 (UMLS CUI [1,1])
C0770893 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0770893 (UMLS CUI [2,2])