ID

16781

Description

LANN-study: Lantus, Amaryl, Novorapid, Novomix Study; ODM derived from: https://clinicaltrials.gov/show/NCT00151697

Link

https://clinicaltrials.gov/show/NCT00151697

Keywords

Versions (1)
  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 Mellitus Type II NCT00151697

English

Eligibility Diabetes Mellitus Type II NCT00151697

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and hba1c over 7.5% for three months or more
Description

mean fasting blood glucose and hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2]
C0202054
bmi 25 - 35 kg/m2
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fasting plasma c-peptide level over 0.3 nmol/l
Description

fasting plasma c-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
stable metformin and sulfonylurea dose for at least three months
Description

stable metformin and sulfonylurea dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
stable weight for at least three months (change maximal 2 kg)
Description

Stable weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fasting glucose over 25 mmol/l
Description

Fasting glucose

Data type

boolean

Alias
UMLS CUI [1]
C0202045
use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
Description

Use of alpha-glucosidase inhibitors or thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1299007
UMLS CUI [2]
C1257987
renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
Description

Renal or liver failure

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0428321
heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
alcohol more than two units per day
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0038586
inflammatory or infectious diseases
Description

inflammatory or infectious diseases

Data type

boolean

Alias
UMLS CUI [1]
C1290884
UMLS CUI [2]
C0009450
unstable chronic disease
Description

unstable chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
discontinuation of smoking within three months of randomisation date
Description

discontinuation of smoking

Data type

boolean

Alias
UMLS CUI [1]
C0425310
allergy for or intolerance of glimepiride or novorapid.
Description

allergy for or intolerance of glimepiride or novorapid

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0061323
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0939412
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Similar models

Eligibility Diabetes Mellitus Type II NCT00151697

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
mean fasting blood glucose and hba1c
Item
failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and hba1c over 7.5% for three months or more
boolean
C0428568 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
BMI
Item
bmi 25 - 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
fasting plasma c-peptide level
Item
fasting plasma c-peptide level over 0.3 nmol/l
boolean
C2208720 (UMLS CUI [1])
stable metformin and sulfonylurea dose
Item
stable metformin and sulfonylurea dose for at least three months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Stable weight
Item
stable weight for at least three months (change maximal 2 kg)
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fasting glucose
Item
fasting glucose over 25 mmol/l
boolean
C0202045 (UMLS CUI [1])
Use of alpha-glucosidase inhibitors or thiazolidinediones
Item
use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
boolean
C1299007 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Renal or liver failure
Item
renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
boolean
C0201976 (UMLS CUI [1])
C0428321 (UMLS CUI [2])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Alcohol consumption
Item
alcohol more than two units per day
boolean
C0038586 (UMLS CUI [1])
inflammatory or infectious diseases
Item
inflammatory or infectious diseases
boolean
C1290884 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
unstable chronic disease
Item
unstable chronic disease
boolean
C0009488 (UMLS CUI [1])
discontinuation of smoking
Item
discontinuation of smoking within three months of randomisation date
boolean
C0425310 (UMLS CUI [1])
allergy for or intolerance of glimepiride or novorapid
Item
allergy for or intolerance of glimepiride or novorapid.
boolean
C0020517 (UMLS CUI [1,1])
C0061323 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0939412 (UMLS CUI [2,2])
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