ID

38847

Beschreibung

Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01045447

Link

https://clinicaltrials.gov/show/NCT01045447

Stichworte

Versionen (1)
  1. 09.11.19 09.11.19 -
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See clinicaltrials.gov

Hochgeladen am

9. November 2019

DOI

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Eligibility Diabetes NCT01045447

Englisch

Eligibility Diabetes NCT01045447

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045447
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine hagedorn [nph] insulin) once daily (od), for at least 3 months
Beschreibung

Insulin regime Basal insulin Once daily | Insulin detemir | Insulin Glargine | Insulin NPH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0650607
UMLS CUI [1,3]
C0556983
UMLS CUI [2]
C0537270
UMLS CUI [3]
C0907402
UMLS CUI [4]
C0021658
ongoing treatment with: metformin with or without other oral antidiabetic drugs (oads) for at least 3 months prior to randomisation
Beschreibung

Metformin | Antidiabetics Oral | Antidiabetics Oral Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332197
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi maximum 40.0 kg/m^2
Beschreibung

Body mass index Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0806909
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or nph insulin) od within 3 months prior to visit 1
Beschreibung

Insulin regime | Exception Basal insulin | Exception Insulin detemir | Exception Insulin Glargine | Exception Insulin NPH

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0650607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0537270
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0907402
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0021658
treatment with glucagon-like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1
Beschreibung

GLP-1 Receptor Agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C2917359
current rosiglitazone users
Beschreibung

rosiglitazone

Datentyp

boolean

Alias
UMLS CUI [1]
C0289313
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
impaired liver function, defined as alanine aminotransferase (alat) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
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 hereof (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 NCT01045447

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045447
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Insulin regime Basal insulin Once daily | Insulin detemir | Insulin Glargine | Insulin NPH
Item
treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine hagedorn [nph] insulin) once daily (od), for at least 3 months
boolean
C0557978 (UMLS CUI [1,1])
C0650607 (UMLS CUI [1,2])
C0556983 (UMLS CUI [1,3])
C0537270 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C0021658 (UMLS CUI [4])
Metformin | Antidiabetics Oral | Antidiabetics Oral Absent
Item
ongoing treatment with: metformin with or without other oral antidiabetic drugs (oads) for at least 3 months prior to randomisation
boolean
C0025598 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index Maximum
Item
bmi maximum 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Exception Basal insulin | Exception Insulin detemir | Exception Insulin Glargine | Exception Insulin NPH
Item
treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or nph insulin) od within 3 months prior to visit 1
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0021658 (UMLS CUI [5,2])
GLP-1 Receptor Agonist
Item
treatment with glucagon-like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1
boolean
C2917359 (UMLS CUI [1])
rosiglitazone
Item
current rosiglitazone users
boolean
C0289313 (UMLS CUI [1])
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])
Liver Dysfunction | Alanine aminotransferase increased
Item
impaired liver function, defined as alanine aminotransferase (alat) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
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 hereof (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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