ID

29252

Descripción

Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01009580

Link

https://clinicaltrials.gov/show/NCT01009580

Palabras clave

Versiones (1)
  1. 12/3/18 12/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01009580

Inglés

Eligibility Diabetes NCT01009580

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01009580
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Descripción

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (od) or twice daily (bid), with or without oral antidiabetic drugs) (oads) (metformin, sulphonylurea (su), glinides, alpha-glucosidase inhibitor, dpp-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before visit 1
Descripción

Premixed insulin Frequency | Insulin Analog Frequency | Other Coding | Antidiabetics Oral | Metformin | Sulfonylurea | Glinides | alpha-Glucosidase Inhibitors | Dipeptidyl Peptidase 4 Inhibitors | pioglitazone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2069057
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C2825028
UMLS CUI [2,2]
C0439603
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0025598
UMLS CUI [6]
C0038766
UMLS CUI [7]
C3537178
UMLS CUI [8]
C1299007
UMLS CUI [9]
C2917254
UMLS CUI [10]
C0071097
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) below or equal to 40.0 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
Descripción

Insulin regime | Exception Inclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
treatment with rosiglitazone or glucagon-like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
Descripción

rosiglitazone | GLP-1 Receptor Agonist | exenatide | liraglutide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C2917359
UMLS CUI [3]
C0167117
UMLS CUI [4]
C1456408
cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Descripción

Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0581377
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0162577
uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg)
Descripción

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer
Descripción

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
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Similar models

Eligibility Diabetes NCT01009580

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01009580
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Premixed insulin Frequency | Insulin Analog Frequency | Other Coding | Antidiabetics Oral | Metformin | Sulfonylurea | Glinides | alpha-Glucosidase Inhibitors | Dipeptidyl Peptidase 4 Inhibitors | pioglitazone
Item
subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (od) or twice daily (bid), with or without oral antidiabetic drugs) (oads) (metformin, sulphonylurea (su), glinides, alpha-glucosidase inhibitor, dpp-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before visit 1
boolean
C2069057 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C2825028 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5])
C0038766 (UMLS CUI [6])
C3537178 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C2917254 (UMLS CUI [9])
C0071097 (UMLS CUI [10])
Glucohemoglobin measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Exception Inclusion criteria
Item
treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
rosiglitazone | GLP-1 Receptor Agonist | exenatide | liraglutide
Item
treatment with rosiglitazone or glucagon-like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
boolean
C0289313 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
C1456408 (UMLS CUI [4])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg)
boolean
C4013784 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C4013784 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
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