ID

29251

Description

Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01006291

Link

https://clinicaltrials.gov/show/NCT01006291

Keywords

Versions (1)
  1. 3/12/18 3/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01006291

English

Eligibility Diabetes NCT01006291

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01006291
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
current treatment: oral anti-diabetic drug(s) (oad(s)) alone, basal insulin alone or the combination of oad(s) and basal insulin. allowed oads are: metformin, insulin secretagogues (sulphonylureas (su) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to visit 1
Description

Antidiabetics Oral Dose unchanged | Basal insulin | Combined Modality Therapy | Metformin | Pills Insulin Releasing | Sulfonylurea | Glinides | pioglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0442739
UMLS CUI [2]
C0650607
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0025598
UMLS CUI [5,1]
C0994475
UMLS CUI [5,2]
C0021641
UMLS CUI [5,3]
C1283071
UMLS CUI [6]
C0038766
UMLS CUI [7]
C3537178
UMLS CUI [8]
C0071097
hba1c: oads only users 7.0-11.0 % (both inclusive), basal insulin with/without oads users 7.0-10.0% (both inclusive) by central laboratory analysis
Description

Glucohemoglobin measurement | Antidiabetics Oral | Basal insulin

Data type

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0650607
body mass index (bmi) below or equal to 40.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cancer and medical history of cancer hereof
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
use within the last 3 months prior to visit 1 of: glucagon-like peptide-1(glp-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase-inhibitors
Description

GLP-1 Receptor Agonist | exenatide | liraglutide | rosiglitazone | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C0289313
UMLS CUI [5]
C2917254
UMLS CUI [6]
C1299007
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

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

Data type

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
Description

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

Data type

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 hereof (except basal cell skin cancer and squamous cell skin cancer)
Description

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

Data type

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 NCT01006291

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01006291
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])
Antidiabetics Oral Dose unchanged | Basal insulin | Combined Modality Therapy | Metformin | Pills Insulin Releasing | Sulfonylurea | Glinides | pioglitazone
Item
current treatment: oral anti-diabetic drug(s) (oad(s)) alone, basal insulin alone or the combination of oad(s) and basal insulin. allowed oads are: metformin, insulin secretagogues (sulphonylureas (su) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to visit 1
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0442739 (UMLS CUI [1,4])
C0650607 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0994475 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C1283071 (UMLS CUI [5,3])
C0038766 (UMLS CUI [6])
C3537178 (UMLS CUI [7])
C0071097 (UMLS CUI [8])
Glucohemoglobin measurement | Antidiabetics Oral | Basal insulin
Item
hba1c: oads only users 7.0-11.0 % (both inclusive), basal insulin with/without oads users 7.0-10.0% (both inclusive) by central laboratory analysis
boolean
C0202054 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3])
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)
Malignant Neoplasms
Item
cancer and medical history of cancer hereof
boolean
C0006826 (UMLS CUI [1])
GLP-1 Receptor Agonist | exenatide | liraglutide | rosiglitazone | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors
Item
use within the last 3 months prior to visit 1 of: glucagon-like peptide-1(glp-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase iv (dpp-iv) inhibitors, alpha-glucosidase-inhibitors
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C0289313 (UMLS CUI [4])
C2917254 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
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 hereof (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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