ID

29249

Beschrijving

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

Trefwoorden

  1. 11-03-18 11-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 maart 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes NCT00982644

Eligibility Diabetes NCT00982644

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00982644
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

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

Antidiabetics Oral Dose unchanged

Datatype

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%
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

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

Body mass index

Datatype

boolean

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

Period Extension | Therapeutic procedure Period Completion

Datatype

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
Beschrijving

Exclusion Criteria

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

exenatide | liraglutide

Datatype

boolean

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

Cardiovascular Disease

Datatype

boolean

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

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Diabetes NCT00982644

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00982644
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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