Gender | Diabetes Mellitus, Insulin-Dependent | Glycosylated hemoglobin A | Insulin regime Basal insulin Bolus | Insulin regime Duration Informed Consent Date
Item
men or women with type 1 diabetes mellitus, an hba1c range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. they must have had at least 1 year of continuous insulin treatment at the date of informed consent.
boolean
C0079399 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
C0557978 (UMLS CUI [4,1])
C0650607 (UMLS CUI [4,2])
C1705509 (UMLS CUI [4,3])
C0557978 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C2985782 (UMLS CUI [5,3])
Oral hypoglycemic | Insulin
Item
subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
Adrenal Cortex Hormones Intravenous
Item
subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
boolean
C0001617 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Investigational New Drug
Item
subjects who were treated with another investigational product within 12 weeks prior to informed consent
boolean
C0013230 (UMLS CUI [1])
Illicit drug use Study Protocol
Item
subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Malignant Neoplasms | Complication Serious Limiting Protocol Compliance | Complication Serious Limiting research results | Systemic disease Limiting Protocol Compliance | Systemic disease Limiting research results
Item
subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or 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])
C0009566 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0525058 (UMLS CUI [6,4])
C0009566 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0442893 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0442893 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C0683954 (UMLS CUI [9,3])
Pancreatectomy | Pancreas Transplantation | Islets of Langerhans Transplantation
Item
subjects who have undergone pancreatectomy or pancreas/islet cell transplant
boolean
C0030279 (UMLS CUI [1])
C0030275 (UMLS CUI [2])
C0079646 (UMLS CUI [3])
Night shift worker
Item
night shift workers
boolean
C0555008 (UMLS CUI [1])
Protocol Compliance Unlikely | Clinical Study Follow-up Unsuccessful
Item
subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Insulin, Glulisine, Human
Item
subjects who have previously been treated with hmr1964
boolean
C1313386 (UMLS CUI [1])
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])
Pregnancy Possible | Childbearing Potential | serum human chorionic gonadotropin (hCG) measurement
Item
female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hcg) level > 0.7 miu/ml as determined by central laboratory, srl medisearch inc., during screening phase]
boolean
C0032961 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2])
C2208823 (UMLS CUI [3])
Diabetic Retinopathy | Operative Surgical Procedures | Laser photocoagulation | Vitrectomy
Item
subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
boolean
C0011884 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0441510 (UMLS CUI [3])
C0042903 (UMLS CUI [4])
Alcohol abuse
Item
subjects with history of alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Hypersensitivity Insulin
Item
subjects with hypersensitivity to insulin preparations
boolean
C0020517 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
Hepatic impairment | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal Insufficiency | Creatinine measurement, serum
Item
subjects with impaired hepatic function (sgot or sgpt ³=<80 iu/l determined by central laboratory, srl medisearch inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dl determined by central laboratory, srl medisearch inc., during screening phase)
boolean
C0948807 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Other Reason Study Subject Inappropriate
Item
subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
boolean
C3840932 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])