ID

38847

Description

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

Keywords

Versions (1)
  1. 11/9/19 11/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 9, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes NCT01045447

English

Eligibility Diabetes NCT01045447

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045447
Inclusion Criteria
Description

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

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
Description

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

Data type

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
Description

Metformin | Antidiabetics Oral | Antidiabetics Oral Absent

Data type

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
Description

Hemoglobin A1c measurement

Data type

boolean

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

Body mass index Maximum

Data type

boolean

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

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
Description

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

Data type

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
Description

GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C2917359
current rosiglitazone users
Description

rosiglitazone

Data type

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
Description

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

Data type

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)
Description

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

Data type

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)
Description

Liver Dysfunction | Alanine aminotransferase increased

Data type

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
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Data type

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)
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Diabetes NCT01045447

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045447
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial