ID

38651

Description

A Study in Adults With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01421459

Link

https://clinicaltrials.gov/show/NCT01421459

Keywords

Versions (1)
  1. 10/29/19 10/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01421459

English

Eligibility Diabetes Mellitus, Type 2 NCT01421459

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus based on the disease diagnostic criteria world health organization (who) classification
Description

Non-Insulin-Dependent Diabetes Mellitus WHO classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
Description

Antidiabetics Oral Type Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332307
UMLS CUI [1,4]
C1265611
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
Description

Hemoglobin A1c measurement | Insulin Absent | Lantus

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0876064
have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have significant liver, cardiac or gastrointestinal disease
Description

Liver disease | Heart Disease | Gastrointestinal Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0017178
have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
have an excessive resistance to insulin or hypersensitivity to lantus
Description

Insulin Resistance Excessive | Hypersensitivity Lantus

Data type

boolean

Alias
UMLS CUI [1,1]
C0021655
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0876064
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
Description

Episode Quantity Hypoglycemia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
UMLS CUI [1,4]
C0205082
have taken any other insulin other than lantus within the past 30 days
Description

Insulin used | Exception Lantus

Data type

boolean

Alias
UMLS CUI [1]
C0240016
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0876064
taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Description

Antidiabetics Illicit

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332266
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01421459

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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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