ID

16781

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00151697

Nyckelord

  1. 2016-08-07 2016-08-07 -
Uppladdad den

7 augusti 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus Type II NCT00151697

Eligibility Diabetes Mellitus Type II NCT00151697

Inclusion Criteria
Beskrivning

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
Beskrivning

mean fasting blood glucose and hba1c

Datatyp

boolean

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

BMI

Datatyp

boolean

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

fasting plasma c-peptide level

Datatyp

boolean

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

stable metformin and sulfonylurea dose

Datatyp

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)
Beskrivning

Stable weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Fasting glucose

Datatyp

boolean

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

Use of alpha-glucosidase inhibitors or thiazolidinediones

Datatyp

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
Beskrivning

Renal or liver failure

Datatyp

boolean

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

Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

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

Alcohol consumption

Datatyp

boolean

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

inflammatory or infectious diseases

Datatyp

boolean

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

unstable chronic disease

Datatyp

boolean

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

discontinuation of smoking

Datatyp

boolean

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

allergy for or intolerance of glimepiride or novorapid

Datatyp

boolean

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

Similar models

Eligibility Diabetes Mellitus Type II NCT00151697

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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