ID

38923

Beschrijving

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01513590

Link

https://clinicaltrials.gov/show/NCT01513590

Trefwoorden

Versies (1)
  1. 13-11-19 13-11-19 -
Houder van rechten

See clinicaltrials.gov

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13 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT01513590

Engels

Eligibility Diabetes NCT01513590

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01513590
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (oads): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (visit 2) 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 (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - dpp-iv inhibitor: minimum 100 mg daily or according to local labelling,
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0994475
UMLS CUI [4,2]
C1283071
UMLS CUI [4,3]
C0021641
UMLS CUI [5]
C0038766
UMLS CUI [6]
C3537178
UMLS CUI [7]
C2917254
UMLS CUI [8]
C1299007
UMLS CUI [9,1]
C0025598
UMLS CUI [9,2]
C0178602
UMLS CUI [9,3]
C0456683
UMLS CUI [10,1]
C0025598
UMLS CUI [10,2]
C0752079
alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
Beschrijving

alpha-Glucosidase Inhibitors Dose Minimum | alpha-Glucosidase Inhibitors Maximum Tolerated Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299007
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1524031
UMLS CUI [2,1]
C1299007
UMLS CUI [2,2]
C0752079
insulin naïve subject; allowed is: previous short term insulin treatment up to 14 days
Beschrijving

Insulin Absent | Insulin regime short-term allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
insulin naïve subject; allowed is: treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
Beschrijving

Insulin Absent | Treatment Hospitalization allowed | Treatment Gestational Diabetes allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0085207
UMLS CUI [3,3]
C0683607
hba1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below or equal to 40.0 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 12 weeks prior to visit 1 (screening)
Beschrijving

Thiazolidinediones | GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2917359
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and mao inhibitors
Beschrijving

Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0026457
anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
Beschrijving

Lifestyle changes | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Variation Eating habit

Datatype

boolean

Alias
UMLS CUI [1]
C0870811
UMLS CUI [2]
C1658633
UMLS CUI [3,1]
C0555008
UMLS CUI [3,2]
C0205355
UMLS CUI [4,1]
C4316563
UMLS CUI [4,2]
C0205355
UMLS CUI [5,1]
C0205419
UMLS CUI [5,2]
C1266864
cardiovascular disease, within the last 24 weeks prior to trial start, defined as: stroke; decompensated heart failure nyha (new york heart association) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Beschrijving

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

Datatype

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
any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
Beschrijving

Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0011860
previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
known or suspected hypersensitivity to trial products or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
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Similar models

Eligibility Diabetes NCT01513590

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01513590
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin | Combined Modality Therapy | Antidiabetics Oral | Pills Releasing Insulin | Sulfonylurea | Glinides | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Metformin Dose U/day | Metformin Maximum Tolerated Dose
Item
current treatment: metformin monotherapy or metformin in any combination with one of the following oral anti-diabetic drugs (oads): insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alpha-glucosidase inhibitors for at least 12 weeks prior to randomisation (visit 2) 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 (sulphonylurea or glinide): minimum half of the daily maximum dose according to local labelling, - dpp-iv inhibitor: minimum 100 mg daily or according to local labelling,
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0994475 (UMLS CUI [4,1])
C1283071 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5])
C3537178 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0025598 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0456683 (UMLS CUI [9,3])
C0025598 (UMLS CUI [10,1])
C0752079 (UMLS CUI [10,2])
alpha-Glucosidase Inhibitors Dose Minimum | alpha-Glucosidase Inhibitors Maximum Tolerated Dose
Item
alpha-glucosidase-inhibitors: minimum half of the daily maximum dose or maximum tolerated dose
boolean
C1299007 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C1299007 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
Insulin Absent | Insulin regime short-term allowed
Item
insulin naïve subject; allowed is: previous short term insulin treatment up to 14 days
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Insulin Absent | Treatment Hospitalization allowed | Treatment Gestational Diabetes allowed
Item
insulin naïve subject; allowed is: treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0085207 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) between 7.0-10.0 % (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
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)
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 12 weeks prior to visit 1 (screening)
boolean
C1257987 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and mao inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0026457 (UMLS CUI [4])
Lifestyle changes | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Variation Eating habit
Item
anticipated significant lifestyle changes during the trial according to the discretion of the trial physician, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
boolean
C0870811 (UMLS CUI [1])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C0205419 (UMLS CUI [5,1])
C1266864 (UMLS CUI [5,2])
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 24 weeks prior to trial start, defined as: stroke; decompensated heart failure nyha (new york heart association) 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])
Disease Interferes with Research results | Exception Condition Associated with Non-Insulin-Dependent Diabetes Mellitus
Item
any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the trial physician's opinion could interfere with the results of the trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0011860 (UMLS CUI [2,4])
Study Subject Participation Status
Item
previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
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