Age
Item
male or female subjects aged between 35 and 70 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
type 2 diabetes with duration >6 months and <10 years
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Insulin, Long-Acting | Intermediate-acting insulin | Insulin Glargine | Insulin detemir | Insulin, isophane | Metformin Dose Stable | Sulfonylureas Dose Stable | Combined Modality Therapy
Item
for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or nph insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
boolean
C0304870 (UMLS CUI [1])
C0304869 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
C0021658 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0038766 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0009429 (UMLS CUI [8])
Hemoglobin A1c measurement
Item
hba1c >=7.0% and <=10.0%
boolean
C0474680 (UMLS CUI [1])
Antihypertensive Agents Stable | Hypolipidemic Agents Stable
Item
if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
boolean
C0003364 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0086440 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Malignant Neoplasms | Disease Relevance Clinical
Item
history or presence of cancer or any clinically relevant diseases
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
chronic heart failure nyha class iii or iv, unstable angina pectoris or myocardial infarction within the previous 6 months
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Recurrent hypoglycemia
Item
recurrent hypoglycemia
boolean
C1846288 (UMLS CUI [1])
Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender
Item
abnormal lab tests at screening (alat and/or asat >=3 times uln), creatinine >1.6 mg/dl in males and >1.4 mg/dl in females
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
ECG finding Relevance Clinical
Item
clinically relevant ecg findings at screening
boolean
C0438154 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Insulin, Short-Acting | Insulin Formulation Mixed
Item
treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
boolean
C0356365 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
Oral hypoglycemic | Exception Metformin | Exception Sulfonylureas
Item
treatment with any other oha than metformin or metformin plus sulfonylureas during the previous 3 months
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
Systemic therapy | Topical administration of treatment | Pharmaceutical Preparations Influence Glucose metabolism
Item
any systemic or topical treatment with drugs known to influence glucose metabolism
boolean
C1515119 (UMLS CUI [1])
C0001566 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])