ID

22869

Description

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00605475

Link

https://clinicaltrials.gov/show/NCT00605475

Keywords

  1. 6/13/17 6/13/17 -
Uploaded on

June 13, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT00605475

Eligibility Type 2 Diabetes Mellitus NCT00605475

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
Description

gender, age, type 2 diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0011860
hba1c between 7.0 and 9.5%
Description

hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
on stable dose metformin monotherapy
Description

stable dose metformin monotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0205360
stable body weight
Description

stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
Description

poorly controlled type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0860161
acute infections prior to dosing
Description

acute infections

Data type

boolean

Alias
UMLS CUI [1]
C0275518
patients with type 1 diabetes (insulin-dependent diabetes)
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
taking diabetes medication (other than metformin)
Description

diabetes medication

Data type

boolean

Alias
UMLS CUI [1]
C0935929
other protocol-defined inclusion/exclusion criteria may apply
Description

other criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1512693

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00605475

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender, age, type 2 diabetes mellitus
Item
male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
hba1c
Item
hba1c between 7.0 and 9.5%
boolean
C0019018 (UMLS CUI [1])
stable dose metformin monotherapy
Item
on stable dose metformin monotherapy
boolean
C0025598 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
stable body weight
Item
stable body weight
boolean
C0517386 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
poorly controlled type 2 diabetes
Item
poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
boolean
C0011860 (UMLS CUI [1,1])
C0860161 (UMLS CUI [1,2])
acute infections
Item
acute infections prior to dosing
boolean
C0275518 (UMLS CUI [1])
type 1 diabetes
Item
patients with type 1 diabetes (insulin-dependent diabetes)
boolean
C0011854 (UMLS CUI [1])
diabetes medication
Item
taking diabetes medication (other than metformin)
boolean
C0935929 (UMLS CUI [1])
other criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0205394 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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