ID

29233

Description

Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00807092

Lien

https://clinicaltrials.gov/show/NCT00807092

Mots-clés

Versions (1)
  1. 10/03/2018 10/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

10 mars 2018

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 NCT00807092

Anglais

Eligibility Diabetes NCT00807092

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00807092
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes diagnosed 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-naive (less than or equal to 1 week of daily use of insulin therapy)
Description

Insulin naive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
treatment with metformin as monotherapy or in combination therapy with other oad(s) for at least 3 months prior to this trial
Description

Metformin | Combined Modality Therapy | Antidiabetics Oral

Type de données

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
Description

Metformin U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
currently at least one of other oad(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
Description

Antidiabetics Oral Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
glycosylated haemoglobin (hba1c) between 7.5-11.0%
Description

Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) between 18.5 - 35.0 kg/m^2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
be able and willing to perform continuous glucose monitoring system (cgms ) and self-monitored blood glucose (smbg)
Description

Glucose monitoring system Continuous | Blood Glucose Self-Monitoring

Type de données

boolean

Alias
UMLS CUI [1,1]
C3873850
UMLS CUI [1,2]
C0549178
UMLS CUI [2]
C0005803
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy 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
any contraindication of metformin
Description

Medical contraindication Metformin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
receipt of investigational drug within the last 3 months prior to this trial
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
any history of chronic insulin therapy (more than 1 week of daily use)
Description

Insulin regime chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205191
systemically treated with thiazolidinediones (tzds) for more than one month within 6 months prior to this trial
Description

Systemic therapy Thiazolidinediones

Type de données

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1257987
pregnancy, nursing mother, or unwillingness to use adequate contraception
Description

Pregnancy | Breast Feeding | Contraceptive methods Unwilling

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
Retour au début de la page

Similar models

Eligibility Diabetes NCT00807092

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00807092
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 diagnosed for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin naive
Item
insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Metformin | Combined Modality Therapy | Antidiabetics Oral
Item
treatment with metformin as monotherapy or in combination therapy with other oad(s) for at least 3 months prior to this trial
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Metformin U/day
Item
currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Antidiabetics Oral Quantity
Item
currently at least one of other oad(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
glycosylated haemoglobin (hba1c) between 7.5-11.0%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18.5 - 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glucose monitoring system Continuous | Blood Glucose Self-Monitoring
Item
be able and willing to perform continuous glucose monitoring system (cgms ) and self-monitored blood glucose (smbg)
boolean
C3873850 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy 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])
Medical contraindication Metformin
Item
any contraindication of metformin
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Investigational New Drugs
Item
receipt of investigational drug within the last 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Insulin regime chronic
Item
any history of chronic insulin therapy (more than 1 week of daily use)
boolean
C0557978 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Systemic therapy Thiazolidinediones
Item
systemically treated with thiazolidinediones (tzds) for more than one month within 6 months prior to this trial
boolean
C1515119 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling
Item
pregnancy, nursing mother, or unwillingness to use adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
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