ID

29214

Description

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs; ODM derived from: https://clinicaltrials.gov/show/NCT00537277

Link

https://clinicaltrials.gov/show/NCT00537277

Keywords

Versions (1)
  1. 3/8/18 3/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00537277

English

Eligibility Diabetes NCT00537277

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00537277
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus for more than 12 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c: 7.5 - 11.0%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
an antidiabetic regimen that has been stable for at least 3 months prior to screening
Description

Antidiabetics Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0205360
an antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (oads) or 1 oad plus evening or bedtime basal insulin
Description

Antidiabetics Oral Quantity | Evening Basal insulin | Bedtime Basal insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0587117
UMLS CUI [2,2]
C0650607
UMLS CUI [3,1]
C0521112
UMLS CUI [3,2]
C0650607
oads dosed at 50% or more of the maximum recommended dose
Description

Antidiabetics Oral Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any insulin preparations other than nph or glargine within the past 6 months
Description

Insulin | Exception NPH insulin | Exception Insulin Glargine

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021658
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0907402
use of more than 60 units of insulin per day
Description

Insulin U/day Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C1265611
morning time insulin administration
Description

Administration of insulin Morning

Data type

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0332170
use of more than one insulin dose daily
Description

Insulin Dose Quantity per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
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Similar models

Eligibility Diabetes NCT00537277

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00537277
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for more than 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c: 7.5 - 11.0%
boolean
C0202054 (UMLS CUI [1])
Antidiabetics Stable
Item
an antidiabetic regimen that has been stable for at least 3 months prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Evening Basal insulin | Bedtime Basal insulin
Item
an antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (oads) or 1 oad plus evening or bedtime basal insulin
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0587117 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C0521112 (UMLS CUI [3,1])
C0650607 (UMLS CUI [3,2])
Antidiabetics Oral Dosage
Item
oads dosed at 50% or more of the maximum recommended dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Insulin | Exception NPH insulin | Exception Insulin Glargine
Item
use of any insulin preparations other than nph or glargine within the past 6 months
boolean
C0021641 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021658 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0907402 (UMLS CUI [3,2])
Insulin U/day Quantity
Item
use of more than 60 units of insulin per day
boolean
C0021641 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Administration of insulin Morning
Item
morning time insulin administration
boolean
C0199782 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
Insulin Dose Quantity per day
Item
use of more than one insulin dose daily
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
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