ID

29249

Descripción

Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00982644

Link

https://clinicaltrials.gov/show/NCT00982644

Palabras clave

Versiones (1)
  1. 11/3/18 11/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT00982644

Inglés

Eligibility Diabetes NCT00982644

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00982644
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
treatment with oral antidiabetic drugs (oads) for at least three months before trial start at an unchanged dose
Descripción

Antidiabetics Oral Dose unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0442739
hba1c: 7.0-10.0%
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) no higher than 40.0 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
for the extension trial only: completion of the 52 week treatment period in trial nn1250-3579 (nct00982644)
Descripción

Period Extension | Therapeutic procedure Period Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2347804
UMLS CUI [2,3]
C0205197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with exenatide or liraglutide within the last 3 months before trial start
Descripción

exenatide | liraglutide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C1456408
cardiovascular disease within the last 6 months
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled treated/untreated severe hypertension
Descripción

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332155
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Diabetes NCT00982644

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00982644
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Antidiabetics Oral Dose unchanged
Item
treatment with oral antidiabetic drugs (oads) for at least three months before trial start at an unchanged dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0442739 (UMLS CUI [1,4])
Glucohemoglobin measurement
Item
hba1c: 7.0-10.0%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) no higher than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Period Extension | Therapeutic procedure Period Completion
Item
for the extension trial only: completion of the 52 week treatment period in trial nn1250-3579 (nct00982644)
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
exenatide | liraglutide
Item
treatment with exenatide or liraglutide within the last 3 months before trial start
boolean
C0167117 (UMLS CUI [1])
C1456408 (UMLS CUI [2])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C4013784 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C4013784 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
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