Information:
Fel:
ID
21771
Beskrivning
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00309608
Länk
https://clinicaltrials.gov/show/NCT00309608
Nyckelord
Versioner (1)
- 2017-04-29 2017-04-29 -
Uppladdad den
29 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00309608
Eligibility Diabetes Mellitus, Type 2 NCT00309608
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00309608
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
inclusion criteria
Item
inclusion_criteria:
boolean
C1512693 (UMLS CUI [1])
diabetes mellitus type 2 metformin
Item
male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
boolean
C0011860 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0025598 (UMLS CUI [1,2])
HbA1c with metformin and other oral antidiabetic drug at screening
Item
hba1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
boolean
C0019018 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0359086 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0025598 (UMLS CUI [1,2])
C0359086 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
HbA1c with metformin at screening
Item
hba1c 7.5 10.0% at screening for patients treated with metformin alone
boolean
C0019018 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C0025598 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
HbA1c at placebor run-in phase
Item
hba1c 7.5 10.0% at beginning of the placebo run-in phase
boolean
C0019018 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
C3274438 (UMLS CUI [1,3])
C0032042 (UMLS CUI [1,2])
C3274438 (UMLS CUI [1,3])
age
Item
age > 21 and < 75 years
boolean
C0001779 (UMLS CUI [1])
bmi
Item
bmi > 25 and < 40 kg/m2 (body mass index)
boolean
C1305855 (UMLS CUI [1])
exclusion criteria
Item
exclusion_criteria:
boolean
C0680251 (UMLS CUI [1])
cardiovascular disease
Item
clinically relevant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
impaired hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
impaired renal function
Item
renal insufficiency or impaired renal function
boolean
C1565489 (UMLS CUI [1])
rosiglitazone, pioglitazone
Item
treatment with rosiglitazone or pioglitazone within 6 months prior to screening
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0071097 (UMLS CUI [2])
insulin treatment
Item
treatment with insulin within 3 months prior to screening
boolean
C0745343 (UMLS CUI [1])