ID

34586

Beschrijving

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

Trefwoorden

  1. 19-01-19 19-01-19 -
Houder van rechten

see on clinicaltrials.gov

Geüploaded op

19 januari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT01257451

Eligibility Type 2 Diabetes Mellitus NCT01257451

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

ID.1

Datatype

boolean

patients with a confirmed diagnosis of t2dm
Beschrijving

ID.2

Datatype

boolean

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

ID.3

Datatype

boolean

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

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

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

ID.5

Datatype

boolean

previous or current participation in any vildagliptin clinical study.
Beschrijving

ID.6

Datatype

boolean

history of hypersensitivity to dpp-4 inhibitors.
Beschrijving

ID.7

Datatype

boolean

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

ID.8

Datatype

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
Beschrijving

ID.9

Datatype

boolean

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01257451

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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

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