ID

38862

Beskrivning

Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01076647

Länk

https://clinicaltrials.gov/show/NCT01076647

Nyckelord

Versioner (1)
  1. 2019-11-10 2019-11-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT01076647

Engelsk

Eligibility Diabetes NCT01076647

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01076647
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Beskrivning

Insulin Absent | Insulin short-term allowed | Hospitalization Treatment allowed | Treatment Gestational Diabetes allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0085207
UMLS CUI [4,3]
C0683607
current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-insulin secretagogue (sulfonylurea (su) or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
Beskrivning

Metformin | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Dose unchanged | Dose Minimum U/day | Maximum Tolerated Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0994475
UMLS CUI [3,2]
C1283071
UMLS CUI [3,3]
C0021641
UMLS CUI [4]
C0038766
UMLS CUI [5]
C3537178
UMLS CUI [6]
C2917254
UMLS CUI [7]
C1299007
UMLS CUI [8]
C0050393
UMLS CUI [9,1]
C0178602
UMLS CUI [9,2]
C0442739
UMLS CUI [10,1]
C0178602
UMLS CUI [10,2]
C1524031
UMLS CUI [10,3]
C0456683
UMLS CUI [11,1]
C0752079
UMLS CUI [11,2]
C0456683
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index) below or equal to 45.0 kg/m^2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Thiazolidinediones | exenatide | liraglutide

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Datatyp

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)
Beskrivning

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

Datatyp

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 NCT01076647

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01076647
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent | Insulin short-term allowed | Hospitalization Treatment allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Metformin | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Dose unchanged | Dose Minimum U/day | Maximum Tolerated Dose U/day
Item
current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (su) or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-insulin secretagogue (sulfonylurea (su) or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0994475 (UMLS CUI [3,1])
C1283071 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C3537178 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0050393 (UMLS CUI [8])
C0178602 (UMLS CUI [9,1])
C0442739 (UMLS CUI [9,2])
C0178602 (UMLS CUI [10,1])
C1524031 (UMLS CUI [10,2])
C0456683 (UMLS CUI [10,3])
C0752079 (UMLS CUI [11,1])
C0456683 (UMLS CUI [11,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) below or equal to 45.0 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: thiazoledinediones (tzds), 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
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])
Tillbaka till toppen 

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