ID

16792

Description

Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine; ODM derived from: https://clinicaltrials.gov/show/NCT00518427

Link

https://clinicaltrials.gov/show/NCT00518427

Keywords

  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Type 2 NCT00518427

Eligibility Diabetes Type 2 NCT00518427

Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes inadequately controlled on a combination of oad + nph insulin for more than three months
Description

Type 2 diabetes inadequately controlled on a combination of oad + nph insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0860160
UMLS CUI [2,2]
C0021658
UMLS CUI [3,1]
C0860160
UMLS CUI [3,2]
C0359086
stable oad therapy for at least three months, according to the following specified daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimepiride >2mg, metformin>1000 mg, acarbose >150 mg
Description

Stable oad therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0017628
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0017642
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0061323
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0050393
UMLS CUI [5,2]
C0178602
hba1c > 7,0%
Description

HbA1C

Data type

boolean

Alias
UMLS CUI [1]
C0202054
ability to perform qol assessment
Description

ability to perform qol assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0281588
body mass indes: women <30 and men <32
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
autoimmune diabetes, as defined by who
Description

Autoimmune diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0205734
ongoing treatment with thiazolidinedione drug
Description

Thiazolidinedione

Data type

boolean

Alias
UMLS CUI [1]
C1257987
retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
Description

Retinopathy with surgical treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0011884
UMLS CUI [1,2]
C0543467
drug abuse
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
hypersensitivity to insulin glagine excipients
Description

hypersensitivity to insulin glagine excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0907402
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Diabetes Type 2 NCT00518427

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes inadequately controlled on a combination of oad + nph insulin
Item
patients with type 2 diabetes inadequately controlled on a combination of oad + nph insulin for more than three months
boolean
C0011860 (UMLS CUI [1])
C0860160 (UMLS CUI [2,1])
C0021658 (UMLS CUI [2,2])
C0860160 (UMLS CUI [3,1])
C0359086 (UMLS CUI [3,2])
Stable oad therapy
Item
stable oad therapy for at least three months, according to the following specified daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimepiride >2mg, metformin>1000 mg, acarbose >150 mg
boolean
C0017628 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0017642 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0061323 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0050393 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
HbA1C
Item
hba1c > 7,0%
boolean
C0202054 (UMLS CUI [1])
ability to perform qol assessment
Item
ability to perform qol assessment
boolean
C1321605 (UMLS CUI [1,1])
C0281588 (UMLS CUI [1,2])
BMI
Item
body mass indes: women <30 and men <32
boolean
C1305855 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Autoimmune diabetes
Item
autoimmune diabetes, as defined by who
boolean
C0205734 (UMLS CUI [1])
Thiazolidinedione
Item
ongoing treatment with thiazolidinedione drug
boolean
C1257987 (UMLS CUI [1])
Retinopathy with surgical treatment
Item
retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
boolean
C0011884 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Drug abuse
Item
drug abuse
boolean
C0038586 (UMLS CUI [1])
hypersensitivity to insulin glagine excipients
Item
hypersensitivity to insulin glagine excipients
boolean
C0020517 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])

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