ID

17259

Description

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00332488

Lien

https://clinicaltrials.gov/show/NCT00332488

Mots-clés

Versions (1)
  1. 02/09/2016 02/09/2016 -
Téléchargé le

2 septembre 2016

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 Mellitus, Type 2 NCT00332488

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT00332488

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-smokers with clinical diagnosis of type 2 diabetes mellitus for >or= to 6 months
Description

Non-smoker | Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0011860
stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
Description

Metformin Stable status Quantity per day | Metformin Stable status Maximum Tolerated Dose | Pills Insulin Releasing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0752079
UMLS CUI [3,1]
C0994475
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C1283071
fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
Description

Metformin | Sulfonylurea | Combination Product Acceptable

Type de données

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3,1]
C1880146
UMLS CUI [3,2]
C1879533
hba1c >or= to 7.5% and < or= to 11.0%
Description

Glycosylated hemoglobin A

Type de données

boolean

Alias
UMLS CUI [1]
C0019018
bmi < or = to 40kg/m2.
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
fev1> or = to 70%, total lung capacity and > or =80% dlco > or= to 70%
Description

FEV1 | Total Lung Capacity | DLCO

Type de données

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0040509
UMLS CUI [3]
C1516251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any type of anti-diabetic therapy, other than metformin &
Description

Antidiabetics | Metformin

Type de données

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0025598
secretagogues within the preceding 12 weeks
Description

Pills Insulin Releasing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C1283071
serum creatinine > 1.4mg/dl in female subjects and >1.5mg/dl in male subjects
Description

Creatinine measurement, serum | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
history of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
Description

Chronic Obstructive Airway Disease | Asthma | Pulmonary function tests Clinical Significance | Radiologic finding Clinical Significance

Type de données

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3,1]
C0024119
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C1290916
UMLS CUI [4,2]
C2826293
evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Description

Complications of Diabetes Mellitus Serious Evidence of | Autonomic neuropathy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0259749
Retour au début de la page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00332488

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Diabetes Mellitus, Non-Insulin-Dependent
Item
non-smokers with clinical diagnosis of type 2 diabetes mellitus for >or= to 6 months
boolean
C0337672 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Metformin Stable status Quantity per day | Metformin Stable status Maximum Tolerated Dose | Pills Insulin Releasing
Item
stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0752079 (UMLS CUI [2,3])
C0994475 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1283071 (UMLS CUI [3,3])
Metformin | Sulfonylurea | Combination Product Acceptable
Item
fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1880146 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Glycosylated hemoglobin A
Item
hba1c >or= to 7.5% and < or= to 11.0%
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
bmi < or = to 40kg/m2.
boolean
C1305855 (UMLS CUI [1])
FEV1 | Total Lung Capacity | DLCO
Item
fev1> or = to 70%, total lung capacity and > or =80% dlco > or= to 70%
boolean
C0748133 (UMLS CUI [1])
C0040509 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Metformin
Item
treatment with any type of anti-diabetic therapy, other than metformin &
boolean
C0935929 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Pills Insulin Releasing
Item
secretagogues within the preceding 12 weeks
boolean
C0994475 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1283071 (UMLS CUI [1,3])
Creatinine measurement, serum | Gender
Item
serum creatinine > 1.4mg/dl in female subjects and >1.5mg/dl in male subjects
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Chronic Obstructive Airway Disease | Asthma | Pulmonary function tests Clinical Significance | Radiologic finding Clinical Significance
Item
history of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024119 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1290916 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Complications of Diabetes Mellitus Serious Evidence of | Autonomic neuropathy
Item
evidence of serious complications of diabetes (e.g. autonomic neuropathy)
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0259749 (UMLS CUI [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