ID

22956

Description

Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study; ODM derived from: https://clinicaltrials.gov/show/NCT00539448

Link

https://clinicaltrials.gov/show/NCT00539448

Keywords

  1. 6/18/17 6/18/17 -
Uploaded on

June 18, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 1 NCT00539448

Eligibility Diabetes Mellitus, Type 1 NCT00539448

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed type i diabetic patients
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C1320655
type i diabetes treated with basal-bolus regimen including 3 or more injections of regular human insulin per day
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0087111
bmi, 26-40 kg/m2
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c, 7.5%-10%
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0019018
median 2hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/l)
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0428554
fpg more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/l)
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0428554
willingness to accept, and ability to inject insulin glargine therapy
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0557978
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy : the use of lantus & apidra during pregnancy is not contraindicated. however, in the absence of supportive data, sanofi- aventis pharmaceuticals cannot specifically recommend the use of lantus in this patient population
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0032961
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Description

ID.9

Data type

boolean

Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00539448

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
newly diagnosed type i diabetic patients
boolean
C0011854 (UMLS CUI [1,1])
C1320655 (UMLS CUI [1,2])
ID.2
Item
type i diabetes treated with basal-bolus regimen including 3 or more injections of regular human insulin per day
boolean
C0011854 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
ID.3
Item
bmi, 26-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
ID.4
Item
hba1c, 7.5%-10%
boolean
C0019018 (UMLS CUI [1])
ID.5
Item
median 2hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/l)
boolean
C0428554 (UMLS CUI [1])
ID.6
Item
fpg more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/l)
boolean
C0428554 (UMLS CUI [1])
ID.7
Item
willingness to accept, and ability to inject insulin glargine therapy
boolean
C0557978 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.8
Item
pregnancy : the use of lantus & apidra during pregnancy is not contraindicated. however, in the absence of supportive data, sanofi- aventis pharmaceuticals cannot specifically recommend the use of lantus in this patient population
boolean
C0032961 (UMLS CUI [1])
ID.9
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
boolean

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