Eligibility Diabetes Mellitus, Type 2 NCT01421459

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StudyEvent: Eligibility
1. Eligibility Diabetes Mellitus, Type 2 NCT01421459

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Non-Insulin-Dependent Diabetes Mellitus WHO classification

Item

have type 2 diabetes mellitus based on the disease diagnostic criteria world health organization (who) classification

boolean

C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])

Antidiabetics Oral Type Quantity

Item

have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study

boolean

C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])

Hemoglobin A1c measurement | Insulin Absent | Lantus

Item

have a hemoglobin a1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive if previously on lantus, then hemoglobin a1c must be less than or equal to 11.0 percent

boolean

C0474680 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0876064 (UMLS CUI [3])

Body mass index

Item

have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)

boolean

C1305855 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Liver disease | Heart Disease | Gastrointestinal Disease

Item

have significant liver, cardiac or gastrointestinal disease

boolean

C0023895 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0017178 (UMLS CUI [3])

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in Situ

Item

have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)

boolean

C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])

Insulin Resistance Excessive | Hypersensitivity Lantus

Item

have an excessive resistance to insulin or hypersensitivity to lantus

boolean

C0021655 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0876064 (UMLS CUI [2,2])

Episode Quantity Hypoglycemia Severe

Item

have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study

boolean

C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])

Insulin used | Exception Lantus

Item

have taken any other insulin other than lantus within the past 30 days

boolean

C0240016 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0876064 (UMLS CUI [2,2])

Antidiabetics Illicit

Item

taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin

boolean

C0935929 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])

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Eligibility Diabetes Mellitus, Type 2 NCT01421459