ID

34586

Description

Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01257451

Link

https://clinicaltrials.gov/show/NCT01257451

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

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 NCT01257451

Eligibility Type 2 Diabetes Mellitus NCT01257451

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: ≥ 70 years inclusive at visit 1.
Description

ID.1

Data type

boolean

patients with a confirmed diagnosis of t2dm
Description

ID.2

Data type

boolean

hba1c of ≥ 7% and ≤10.0% by central laboratory at visit 1 and assessed by the investigator to be inadequately controlled
Description

ID.3

Data type

boolean

body mass index (bmi) in the range of 19-45kg/m2
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fpg ≥ 270 mg/dl (≥ 15.0 mmol/l)
Description

ID.5

Data type

boolean

previous or current participation in any vildagliptin clinical study.
Description

ID.6

Data type

boolean

history of hypersensitivity to dpp-4 inhibitors.
Description

ID.7

Data type

boolean

concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
Description

ID.8

Data type

boolean

donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period other protocol-defined inclusion/exclusion criteria may apply
Description

ID.9

Data type

boolean

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01257451

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
age: ≥ 70 years inclusive at visit 1.
boolean
ID.2
Item
patients with a confirmed diagnosis of t2dm
boolean
ID.3
Item
hba1c of ≥ 7% and ≤10.0% by central laboratory at visit 1 and assessed by the investigator to be inadequately controlled
boolean
ID.4
Item
body mass index (bmi) in the range of 19-45kg/m2
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
fpg ≥ 270 mg/dl (≥ 15.0 mmol/l)
boolean
ID.6
Item
previous or current participation in any vildagliptin clinical study.
boolean
ID.7
Item
history of hypersensitivity to dpp-4 inhibitors.
boolean
ID.8
Item
concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
boolean
ID.9
Item
donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period other protocol-defined inclusion/exclusion criteria may apply
boolean

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