ID

38962

Descrição

A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01849289

Link

https://clinicaltrials.gov/show/NCT01849289

Palavras-chave

Versões (1)
  1. 16/11/2019 16/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01849289

Inglês

Eligibility Diabetes NCT01849289

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01849289
Inclusion Criteria
Descrição

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

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)
Descrição

Insulin Absent | Insulin regime short-term allowed | Insulin regime During Hospitalization | Insulin regime During Gestational Diabetes

Tipo de dados

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
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0019993
UMLS CUI [4,1]
C0557978
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C0085207
current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months 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 (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, dpp-iv inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
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]
C2266929
UMLS CUI [6]
C2917254
UMLS CUI [7]
C1299007
UMLS CUI [8]
C0050393
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
hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

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

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with tzds (thiazoledinedione), or glp-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to visit 1 (screening)
Descrição

Thiazolidinediones | GLP-1 Receptor Agonist

Tipo de dados

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, mao (monoamine oxidase) inhibitors
Descrição

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

Tipo de dados

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
cardiovascular disease within the last 6 months prior to visit 1 (screening) 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
Descrição

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

Tipo de dados

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 mellitus, which in the investigator's opinion could interfere with the results of the trial
Descrição

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

Tipo de dados

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
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
known or suspected hypersensitivity to trial product(s) or related products
Descrição

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

Tipo de dados

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 NCT01849289

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01849289
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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 Absent | Insulin regime short-term allowed | Insulin regime During Hospitalization | Insulin regime During Gestational Diabetes
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])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0557978 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0019993 (UMLS CUI [3,3])
C0557978 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C0085207 (UMLS CUI [4,3])
Metformin Dose unchanged | Combined Modality Therapy | Pills Releasing Insulin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | Acarbose | Metformin Dose U/day | Metformin Maximum Tolerated Dose
Item
current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months 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 (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, dpp-iv inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0994475 (UMLS CUI [3,1])
C1283071 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0050393 (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])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 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 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | GLP-1 Receptor Agonist
Item
treatment with tzds (thiazoledinedione), or glp-1 (glucagon-like peptide 1) receptor agonists within the last 3 months 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, mao (monoamine oxidase) 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])
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 (screening) 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 mellitus, which in the investigator'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 product(s) 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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