ID

21771

Description

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

Link

https://clinicaltrials.gov/show/NCT00309608

Keywords

Versions (1)
  1. 4/29/17 4/29/17 -
Uploaded on

April 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00309608

English

Eligibility Diabetes Mellitus, Type 2 NCT00309608

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion_criteria:
Description

inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
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
Description

diabetes mellitus type 2 metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0025598
hba1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
Description

HbA1c with metformin and other oral antidiabetic drug at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C0359086
UMLS CUI [1,4]
C0220908
hba1c 7.5 10.0% at screening for patients treated with metformin alone
Description

HbA1c with metformin at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0025598
UMLS CUI [1,3]
C0220908
hba1c 7.5 10.0% at beginning of the placebo run-in phase
Description

HbA1c at placebor run-in phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0032042
UMLS CUI [1,3]
C3274438
age > 21 and < 75 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi > 25 and < 40 kg/m2 (body mass index)
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion_criteria:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
clinically relevant cardiovascular disease
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
impaired hepatic function
Description

impaired hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
renal insufficiency or impaired renal function
Description

impaired renal function

Data type

boolean

Alias
UMLS CUI [1]
C1565489
treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Description

rosiglitazone, pioglitazone

Data type

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
treatment with insulin within 3 months prior to screening
Description

insulin treatment

Data type

boolean

Alias
UMLS CUI [1]
C0745343
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00309608

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
insulin treatment
Item
treatment with insulin within 3 months prior to screening
boolean
C0745343 (UMLS CUI [1])
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