ID

38850

Description

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01059799

Link

https://clinicaltrials.gov/show/NCT01059799

Keywords

Versions (1)
  1. 11/10/19 11/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01059799

English

Eligibility Diabetes NCT01059799

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01059799
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for japan only: minimum age is 20 years
Description

Japan | Age

Data type

boolean

Alias
UMLS CUI [1]
C0022341
UMLS CUI [2]
C0001779
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 with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a dpp-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. the dose(s) should as minimum be as stated: -insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -metformin: alone or in combination (including fixed combination): maximum tolerated dose - alfa-glucosidase-inhibitors: minimum half of the daily maximal dose or maximum tolerated dose -dpp-4 (dipeptyl peptidase 4) inhibitor: according to local labelling
Description

Pills Releasing Insulin | Sulfonylurea | Glinides | Metformin | Combined Modality Therapy | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Dipeptidyl Peptidase 4 Inhibitors | Dipeptidyl Peptidase 4 Inhibitors Absent | Dose unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C1283071
UMLS CUI [1,3]
C0021641
UMLS CUI [2]
C0038766
UMLS CUI [3]
C3537178
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0009429
UMLS CUI [6]
C1299007
UMLS CUI [7,1]
C1299007
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C2917254
UMLS CUI [9,1]
C2917254
UMLS CUI [9,2]
C0332197
UMLS CUI [10,1]
C0178602
UMLS CUI [10,2]
C0442739
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) no higher than 35.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use within the last 3 months prior to visit 1 of: tzds (thiazolidinediones), exenatide or liraglutide
Description

Thiazolidinediones | exenatide | liraglutide

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0167117
UMLS CUI [3]
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
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
pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
Description

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermatocidal Agents | Contraceptive patch | Hormone implant | Norplant | Contraceptives, Oral | Postmenopausal state | Female Sterilization

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
UMLS CUI [5]
C0042241
UMLS CUI [6,1]
C0009653
UMLS CUI [6,2]
C0682323
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0183461
UMLS CUI [9]
C0493327
UMLS CUI [10]
C0037862
UMLS CUI [11]
C2985284
UMLS CUI [12]
C0848131
UMLS CUI [13]
C1145675
UMLS CUI [14]
C0009905
UMLS CUI [15]
C0232970
UMLS CUI [16]
C0015787
cancer and medical history of cancer (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
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Similar models

Eligibility Diabetes NCT01059799

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01059799
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Japan | Age
Item
for japan only: minimum age is 20 years
boolean
C0022341 (UMLS CUI [1])
C0001779 (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])
Pills Releasing Insulin | Sulfonylurea | Glinides | Metformin | Combined Modality Therapy | alpha-Glucosidase Inhibitors | alpha-Glucosidase Inhibitors Absent | Dipeptidyl Peptidase 4 Inhibitors | Dipeptidyl Peptidase 4 Inhibitors Absent | Dose unchanged
Item
current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a dpp-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. the dose(s) should as minimum be as stated: -insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -metformin: alone or in combination (including fixed combination): maximum tolerated dose - alfa-glucosidase-inhibitors: minimum half of the daily maximal dose or maximum tolerated dose -dpp-4 (dipeptyl peptidase 4) inhibitor: according to local labelling
boolean
C0994475 (UMLS CUI [1,1])
C1283071 (UMLS CUI [1,2])
C0021641 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C3537178 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
C1299007 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C2917254 (UMLS CUI [8])
C2917254 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0178602 (UMLS CUI [10,1])
C0442739 (UMLS CUI [10,2])
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) no higher than 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | exenatide | liraglutide
Item
use within the last 3 months prior to visit 1 of: tzds (thiazolidinediones), exenatide or liraglutide
boolean
C1257987 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
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 | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermatocidal Agents | Contraceptive patch | Hormone implant | Norplant | Contraceptives, Oral | Postmenopausal state | Female Sterilization
Item
pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
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])
C0042241 (UMLS CUI [5])
C0009653 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
C0021900 (UMLS CUI [7])
C0183461 (UMLS CUI [8])
C0493327 (UMLS CUI [9])
C0037862 (UMLS CUI [10])
C2985284 (UMLS CUI [11])
C0848131 (UMLS CUI [12])
C1145675 (UMLS CUI [13])
C0009905 (UMLS CUI [14])
C0232970 (UMLS CUI [15])
C0015787 (UMLS CUI [16])
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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