ID

34586

Descripción

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

Palabras clave

Versiones (1)
  1. 19/1/19 19/1/19 -
Titular de derechos de autor

see on clinicaltrials.gov

Subido en

19 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01257451

Inglés

Eligibility Type 2 Diabetes Mellitus NCT01257451

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

ID.1

Tipo de datos

boolean

patients with a confirmed diagnosis of t2dm
Descripción

ID.2

Tipo de datos

boolean

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

ID.3

Tipo de datos

boolean

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

ID.4

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

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

ID.5

Tipo de datos

boolean

previous or current participation in any vildagliptin clinical study.
Descripción

ID.6

Tipo de datos

boolean

history of hypersensitivity to dpp-4 inhibitors.
Descripción

ID.7

Tipo de datos

boolean

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

ID.8

Tipo de datos

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
Descripción

ID.9

Tipo de datos

boolean

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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01257451

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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