Diabetes Mellitus, Non-Insulin-Dependent | Combined Modality Therapy | Insulin Glargine Maximum Tolerated Dose | Oral hypoglycemic Maximum Tolerated Dose | Insulin | Glucosidase Inhibitor
Item
type 2 diabetes mellitus, previously treated with combination therapy of insulin glargine + oad (maximal tolerated dose / approved in combination with insulin according to local spcs (summary of product characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
boolean
C0011860 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0907402 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0359086 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0021641 (UMLS CUI [5])
C1512211 (UMLS CUI [6])
Glycosylated hemoglobin A
Item
pre-screening hba1c value greater/equal 7% - smaller/equal 9%
boolean
C0019018 (UMLS CUI [1])
Fasting blood glucose measurement
Item
fbg (fasting blood glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
boolean
C0428568 (UMLS CUI [1])
Childbearing Potential | Female Sterilization | Postmenopausal state | Pregnancy | Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms | Spermicides
Item
women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
boolean
C3831118 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
C1874923 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0493327 (UMLS CUI [12])
C0021900 (UMLS CUI [13])
C0221829 (UMLS CUI [14])
C0037862 (UMLS CUI [15])
Blood glucose monitoring Willing | Blood glucose meter | Subject Diary
Item
ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
boolean
C1820407 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0472226 (UMLS CUI [2])
C3890583 (UMLS CUI [3])
Fasting blood glucose measurement Quantity
Item
more than two fbg greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit ii
boolean
C0428568 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Proliferative diabetic retinopathy | Focal photocoagulation | Panretinal photocoagulation | Vitrectomy | Retinal Diseases Unstable Rapidly progressive | Operative Surgical Procedures Patient need for | Laser photocoagulation
Item
active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)
boolean
C0154830 (UMLS CUI [1])
C1302105 (UMLS CUI [2])
C0730064 (UMLS CUI [3])
C0042903 (UMLS CUI [4])
C0035309 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C1838681 (UMLS CUI [5,3])
C0543467 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C0441510 (UMLS CUI [7])
Cardiovascular Diseases Relevant Clinical | Liver diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Interferes with Protocol Compliance | Systemic disease Major Interferes with research results
Item
clinically relevant cardiovascular, hepatic, neurologic, endocrine, 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])
C0442893 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Hepatic Insufficiency | Renal Insufficiency
Item
known impaired hepatic and renal function
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity Insulin | Hypersensitivity Insulin Analogue | Hypersensitivity Insulin Glulisine Excipient
Item
history of hypersensitivity to insulin or insulin analogues or any of the excipients in the insulin glulisine formulation
boolean
C0020517 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1313386 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Investigational New Drugs
Item
treatment with any investigational drug in the last month before visit i
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant or breast-feeding women, or women planning to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Illicit Drugs Study Protocol
Item
treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0086190 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Night shift worker Compliance behavior Limited
Item
night shift workers if they are unable to comply with the treatment regimen
boolean
C0555008 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])