Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. have type 2 diabetes mellitus for at least 1 year.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
2. are at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Hypoglycemic Agents Oral | Insulin Excluded | Metformin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Thiazolidinediones | pioglitazone | rosiglitazone
Item
3. have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1, at or above the doses defined in the following: metformin--1500 milligrams per day (mg/day); sulfonylureas--1/2 the maximum daily dose, according to the local package insert; dipeptidyl peptidase-intravenous (dpp-iv) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; thiazolidinediones (tzds)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
boolean
C0020616 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1827106 (UMLS CUI [5])
C1257987 (UMLS CUI [6])
C0071097 (UMLS CUI [7])
C0289313 (UMLS CUI [8])
Glycosylated hemoglobin A
Item
4. have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
5. body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
boolean
C1305855 (UMLS CUI [1])
Insulin regime
Item
1. have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
boolean
C0557978 (UMLS CUI [1])
Hypoglycemic Agents | Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide
Item
2. have taken any glucose-lowering medications not included in inclusion criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
boolean
C0020616 (UMLS CUI [1])
C0050393 (UMLS CUI [2])
C0066535 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C0246689 (UMLS CUI [6])
C0903898 (UMLS CUI [7])
Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning
Item
3. have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Kidney Transplantation | Renal dialysis | Creatinine measurement, serum
Item
4. have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dl) (177 micromoles per liter [micromol/l]).
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Liver disease Sign or Symptom | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum albumin abnormal
Item
5. have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [alt], or aspartate transaminase [ast] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
boolean
C0023895 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0857878 (UMLS CUI [4])