Non-smoker | Age
Item
non-smoking males and females between 18 and 70 years of age
boolean
C0337672 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) of < 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes mellitus management | Diet therapy Stable | Exercise Stable | Metformin | Sulfonylurea | Meglitinide | alpha-Glucosidase Inhibitors | Dose Adjustment Absent
Item
diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. for subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.
boolean
C0948092 (UMLS CUI [1])
C0012159 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0065880 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C2826232 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Glucohemoglobin measurement | Fasting C-peptide level | Fasting blood glucose measurement Washout Period Fingerstick
Item
hba1c = 6.2 to = 8.5%. fasting c-peptide = 0.5 ng/ml. on the last 3 days of the washout period (day -3, -2, and -1) subjects should have a fbg (finger stick) = 13.5 mmol/l.
boolean
C0202054 (UMLS CUI [1])
C2208720 (UMLS CUI [2])
C0428568 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
C2022094 (UMLS CUI [3,3])
Pulmonary function | Pulmonary function tests
Item
normal pulmonary function and performance on pulmonary function tests
boolean
C0231921 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Antidiabetics | Exception Metformin | Exception Sulfonylurea | Exception Meglitinide | Exception alpha-Glucosidase Inhibitors | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | Symlin | pramlintide acetate | Byetta | exenatide
Item
treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolidinediones (tzds), dipeptyl peptidase inhibitors (dpp-iv), symlin (pramlintide acetate) and or byetta (exenatide)].
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0065880 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1299007 (UMLS CUI [5,2])
C1257987 (UMLS CUI [6])
C1827106 (UMLS CUI [7])
C1174780 (UMLS CUI [8])
C1174779 (UMLS CUI [9])
C1636686 (UMLS CUI [10])
C0167117 (UMLS CUI [11])
Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Study Subject Participation Status
Item
exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
Prescription Drugs | Exception Antidiabetics | Adrenergic alpha-Antagonists allowed | Antihypertensive Agents allowed | Proton Pump Inhibitors allowed | Cholesterol lowering drugs allowed
Item
use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the pi and sponsor. the use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.
boolean
C0304227 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C0001641 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0358591 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0003277 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Improvement Spirometry, before and after bronchodilator | FVC Increase | FEV1 Increase
Item
significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% and 200 ml in either fvc or fev1).
boolean
C2986411 (UMLS CUI [1,1])
C0545456 (UMLS CUI [1,2])
C3714541 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
C0849974 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
Serum creatinine raised
Item
serum creatinine above upper limit of normal (uln) as defined by the laboratory
boolean
C0700225 (UMLS CUI [1])
Condition Study Subject Participation Status Inappropriate | Condition Validity Informed Consent Limited | Condition Study Subject Participation Status Impaired
Item
any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2349101 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])