ID

17302

Description

Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00604344

Link

https://clinicaltrials.gov/show/NCT00604344

Keywords

Versions (1)
  1. 9/5/16 9/5/16 -
Uploaded on

September 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00604344

English

Eligibility Diabetes NCT00604344

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604344
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
duration of diabetes mellitus for at least 2 years
Description

Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
Description

Basal insulin Bolus Therapeutic procedure | Insulin, Long-Acting | Insulins, intermediate-acting | Insulin Aspart

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0304870
UMLS CUI [3]
C3653576
UMLS CUI [4]
C1708521
hba1c below 11.0%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
impaired hepatic function
Description

Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1306571
serious heart diseases
Description

Heart Diseases Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
known hypoglycaemia unawareness or recurrent major hypoglycaemia
Description

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
proliferative retinopathy or maculopathy requiring acute treatment
Description

Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0334094
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0087111
uncontrolled treated/untreated hypertension
Description

Uncontrolled hypertension treated | Uncontrolled hypertension untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
current treatment with total insulin dose of more than 100 iu/day
Description

Insulin regime Dose Total IU/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439810
UMLS CUI [1,4]
C0439465
current treatment or expected at the screening to start treatment with systemic corticosteroids
Description

systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
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Similar models

Eligibility Diabetes NCT00604344

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00604344
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus disease length
Item
duration of diabetes mellitus for at least 2 years
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus Therapeutic procedure | Insulin, Long-Acting | Insulins, intermediate-acting | Insulin Aspart
Item
current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0304870 (UMLS CUI [2])
C3653576 (UMLS CUI [3])
C1708521 (UMLS CUI [4])
Glycosylated hemoglobin A
Item
hba1c below 11.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Hepatic Insufficiency
Item
impaired hepatic function
boolean
C1306571 (UMLS CUI [1])
Heart Diseases Serious
Item
serious heart diseases
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
Proliferative retinopathy Requirement Therapeutic procedure | Disorder of macula of retina Proliferative Requirement Therapeutic procedure
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Uncontrolled hypertension treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Insulin regime Dose Total IU/day
Item
current treatment with total insulin dose of more than 100 iu/day
boolean
C0557978 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0439465 (UMLS CUI [1,4])
systemic steroids
Item
current treatment or expected at the screening to start treatment with systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])
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