Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control Diet | Poor glycemic control Exercise
Item
must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
boolean
C0011860 (UMLS CUI [1])
C0342299 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C0342299 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
Hypoglycemic Agents Absent | Hemoglobin A1c measurement Blood glucose determination by fingerstick
Item
not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (hba1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2,1])
C2022094 (UMLS CUI [2,2])
Hemoglobin A1c measurement Laboratory test finding
Item
have a screening visit hba1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
boolean
C0474680 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
must have a fasting plasma glucose of less than or equal to 300 mg/dl (16.7 mmol/l) prior to randomization
boolean
C0583513 (UMLS CUI [1])
Fasting Blood glucose determination by fingerstick
Item
must have a fasting fingerstick glucose of greater than 120 mg/dl (6.7 mmol/l) performed at home or at the study center prior to randomization
boolean
C0015663 (UMLS CUI [1,1])
C2022094 (UMLS CUI [1,2])
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent | Pancreas Transplantation | Beta cell Transplantation | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0030275 (UMLS CUI [3])
C0030281 (UMLS CUI [4,1])
C0040732 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
C0011849 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
C0030279 (UMLS CUI [6,3])
Fasting C-peptide level | Insulin-Dependent Diabetes Mellitus Possible Clinical Evaluation
Item
fasting c-peptide less than 0.70 ng/ml (0.23 nmol/l) in participants for whom the investigator cannot reasonably exclude t1dm based upon clinical evaluation
boolean
C2208720 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C4084924 (UMLS CUI [2,3])
Fasting blood glucose measurement Self Monitoring Quantity | Diet counseling | Exercise counseling
Item
repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dl (16.7 mmol/l) prior to randomization, despite reinforcement of diet and exercise counseling
boolean
C0428568 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0204932 (UMLS CUI [2])
C0375886 (UMLS CUI [3])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Illness Clinical Significance | Illness Study Subject Participation Status Excluded | Illness Interferes with Interpretation Research results
Item
has history of, or currently active, illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])