ID

29098

Description

Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00437112

Link

https://clinicaltrials.gov/show/NCT00437112

Keywords

Versions (1)
  1. 2/24/18 2/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00437112

English

Eligibility Diabetes Mellitus, Type 2 NCT00437112

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
insulin naive
Description

Insulin naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
one or more oral antihyperglycemic medications
Description

Oral hypoglycemic Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
hba1c greater than or equal to 8.0% and less than or equal to 10.5%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
non-smoker
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
taking a tzd dose greater than what is indicated
Description

Thiazolidinediones Dose Greater Than Indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C1257987
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439093
UMLS CUI [1,4]
C1444656
have not taken insulin within 6 months of entry into study
Description

Insulin Absent Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0449238
have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
Description

Hypoglycemia Severe | Episode Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1265611
have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
Description

Hospitalization Quantity Due to Diabetic - poor control | Emergency department visit Quantity Due to Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0421258
UMLS CUI [2,1]
C0586082
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0421258
have had pneumonia in the 3 months prior to study entry
Description

Pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0032285
systemic glucocorticoid therapy
Description

Glucocorticoid therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C0205373
clinical signs or symptoms of liver disease, acute or chronic hepatitis
Description

Sign or Symptom Liver disease | Hepatitis | Hepatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019189
history of renal transplantation
Description

Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022671
have an active or untreated malignancy
Description

Malignant Neoplasms | Malignant Neoplasms untreated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332155
have a current diagnosis or past history of clinically relevant pulmonary disease
Description

Lung diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024115
taking or have taken exenatide during the 6 weeks prior to study entry
Description

exenatide

Data type

boolean

Alias
UMLS CUI [1]
C0167117
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00437112

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Insulin naive
Item
insulin naive
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Oral hypoglycemic Quantity
Item
one or more oral antihyperglycemic medications
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c greater than or equal to 8.0% and less than or equal to 10.5%
boolean
C0202054 (UMLS CUI [1])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones Dose Greater Than Indicated
Item
taking a tzd dose greater than what is indicated
boolean
C1257987 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439093 (UMLS CUI [1,3])
C1444656 (UMLS CUI [1,4])
Insulin Absent Duration
Item
have not taken insulin within 6 months of entry into study
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Hypoglycemia Severe | Episode Quantity
Item
have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hospitalization Quantity Due to Diabetic - poor control | Emergency department visit Quantity Due to Diabetic - poor control
Item
have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0421258 (UMLS CUI [1,4])
C0586082 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0421258 (UMLS CUI [2,4])
Pneumonia
Item
have had pneumonia in the 3 months prior to study entry
boolean
C0032285 (UMLS CUI [1])
Glucocorticoid therapy Systemic
Item
systemic glucocorticoid therapy
boolean
C0744425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Sign or Symptom Liver disease | Hepatitis | Hepatitis, Chronic
Item
clinical signs or symptoms of liver disease, acute or chronic hepatitis
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
Kidney Transplantation
Item
history of renal transplantation
boolean
C0022671 (UMLS CUI [1])
Malignant Neoplasms | Malignant Neoplasms untreated
Item
have an active or untreated malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Lung diseases
Item
have a current diagnosis or past history of clinically relevant pulmonary disease
boolean
C0024115 (UMLS CUI [1])
exenatide
Item
taking or have taken exenatide during the 6 weeks prior to study entry
boolean
C0167117 (UMLS CUI [1])
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