ID

38851

Beschreibung

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01059812

Link

https://clinicaltrials.gov/show/NCT01059812

Stichworte

Versionen (1)
  1. 10.11.19 10.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. November 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes NCT01059812

Englisch

Eligibility Diabetes NCT01059812

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01059812
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female at least 18 years of age (at least 20 years for japan)
Beschreibung

Age | Japan

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0022341
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
subject on basal human or analogue insulin, once daily (od) or twice daily (bid) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, od or bid, with or without metformin, for at least 3 months
Beschreibung

Basal insulin times per day | Insulin Analogue times per day | Metformin | Metformin Absent | Premixed insulin | Premixed insulin Analogue | Insulin regime Self Mixed | Short-Acting Insulin Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0439511
UMLS CUI [2,1]
C2825028
UMLS CUI [2,2]
C0439511
UMLS CUI [3]
C0025598
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C2069057
UMLS CUI [6,1]
C2069057
UMLS CUI [6,2]
C0243071
UMLS CUI [7,1]
C0557978
UMLS CUI [7,2]
C0036588
UMLS CUI [7,3]
C0205430
UMLS CUI [8,1]
C0356365
UMLS CUI [8,2]
C0439165
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) maximum 35.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with oral antidiabetic drugs (oads) (except metformin) within the last 8 weeks prior to visit 1
Beschreibung

Antidiabetics Oral | Exception Metformin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1
Beschreibung

Thiazolidinediones | GLP-1 Receptor Agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2917359
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
Beschreibung

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

Datentyp

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)
Beschreibung

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
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
Beschreibung

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0455471
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
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Ähnliche Modelle

Eligibility Diabetes NCT01059812

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01059812
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Japan
Item
male or female at least 18 years of age (at least 20 years for japan)
boolean
C0001779 (UMLS CUI [1])
C0022341 (UMLS CUI [2])
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])
Basal insulin times per day | Insulin Analogue times per day | Metformin | Metformin Absent | Premixed insulin | Premixed insulin Analogue | Insulin regime Self Mixed | Short-Acting Insulin Percentage
Item
subject on basal human or analogue insulin, once daily (od) or twice daily (bid) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, od or bid, with or without metformin, for at least 3 months
boolean
C0650607 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C2825028 (UMLS CUI [2,1])
C0439511 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2069057 (UMLS CUI [5])
C2069057 (UMLS CUI [6,1])
C0243071 (UMLS CUI [6,2])
C0557978 (UMLS CUI [7,1])
C0036588 (UMLS CUI [7,2])
C0205430 (UMLS CUI [7,3])
C0356365 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) maximum 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Exception Metformin
Item
treatment with oral antidiabetic drugs (oads) (except metformin) within the last 8 weeks prior to visit 1
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
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])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe 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
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Pregnancy | Breast Feeding | Pregnancy intended | 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])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms | History of cancer | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
boolean
C0006826 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
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