Gender | Diabetes Mellitus, Non-Insulin-Dependent | Body mass index | Glycosylated hemoglobin A
Item
men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a bmi < 30 kg/m2 , a hba1c of > 8.0 - < 11.0% at screening
boolean
C0079399 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
C0019018 (UMLS CUI [4])
C-Peptide Fasting
Item
fasting serum c-peptide at screening > 0.7 ng/ml
boolean
C0006558 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Therapeutic regimen Stable | Sulfonylurea | Informed Consent
Item
subjects who have been on a stable regimen and at the following doses of su for at least 8 weeks prior to signing informed consent
boolean
C1276413 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
glibenclamide
Item
glibenclamide > 5 mg/day
boolean
C0017628 (UMLS CUI [1])
glimepiride
Item
glimepiride > 3 mg/day
boolean
C0061323 (UMLS CUI [1])
Gliclazide In addition to Sulfonylurea | Biguanides
Item
gliclazide > 80 mg/day in addition to receiving the above mentioned su agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
boolean
C0017631 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0038766 (UMLS CUI [1,3])
C0005382 (UMLS CUI [2])
Insulin Glulisine Injection Quantity per day ante cibus Willing
Item
subjects willing to administer three hmr1964 injections per day immediately prior to meals for a 16 week
boolean
C1313386 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C1550738 (UMLS CUI [1,5])
C0600109 (UMLS CUI [1,6])
Insulin Glulisine Receive Unwilling
Item
subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 iu/kg/day of hmr1964
boolean
C1313386 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Oral hypoglycemic | Thiazolidinediones | alpha-Glucosidase Inhibitors | D-phenylalanine Derivative | Insulin | Insulin Glulisine | systemic steroids | Investigational New Drugs
Item
subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional oha (including thiazolidinediones, α-glucosidase inhibitors, d-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than hmr1964, systemic corticosteroids, other investigational products
boolean
C0359086 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C1299007 (UMLS CUI [3])
C0771172 (UMLS CUI [4,1])
C1527240 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
C1313386 (UMLS CUI [6])
C2825233 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Malignant Neoplasms | Systemic disease Major Interferes with Protocol Compliance | Systemic disease Major Interferes with research results
Item
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0006826 (UMLS CUI [5])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
C0442893 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subjects who are pregnant, breast feeding or wish to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Proliferative diabetic retinopathy newly
Item
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent
boolean
C0543467 (UMLS CUI [1,1])
C0011884 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2])
C0042903 (UMLS CUI [3])
C0154830 (UMLS CUI [4,1])
C0750546 (UMLS CUI [4,2])