ID

38962

Description

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

Lien

https://clinicaltrials.gov/show/NCT01849289

Mots-clés

Versions (1)
  1. 16/11/2019 16/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 novembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Diabetes NCT01849289

Anglais

Eligibility Diabetes NCT01849289

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01849289
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

Type de données

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)
Description

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

Type de données

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
Description

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

Type de données

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
Description

Hemoglobin A1c measurement

Type de données

boolean

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

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

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)
Description

Thiazolidinediones | GLP-1 Receptor Agonist

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

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

Type de données

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
Description

Study Subject Participation Status

Type de données

boolean

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

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Diabetes NCT01849289

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01849289
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial