Information:
Fel:
ID
28865
Beskrivning
A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02501161
Länk
https://clinicaltrials.gov/show/NCT02501161
Nyckelord
Versioner (2)
- 2015-08-31 2015-08-31 -
- 2018-02-08 2018-02-08 - Julian Varghese
Rättsinnehavare
ODM derived from: https://clinicaltrials.gov/show/NCT02501161
Uppladdad den
8 februari 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes NCT02501161
Eligibility Diabetes NCT02501161
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT02501161
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
age greater than or equal to 60 years; informed consent; female; time
Item
male or female, age greater than or equal to 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0682069 (UMLS CUI [3])
C0021430 (UMLS CUI [2])
C0682069 (UMLS CUI [3])
diagnosed with type 2 diabetes mellitus.; patients with type 2 diabetes
Item
subjects diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
laboratory; hba1c; both
Item
hba1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
boolean
C0019018 (UMLS CUI [1])
body mass index
Item
body mass index greater than or equal to 20 kg/m^2
boolean
C1305855 (UMLS CUI [1])
treatment; screening; diabetes; insulin; day
Item
insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
boolean
C0021641 (UMLS CUI [1])
C0919936 (UMLS CUI [2])
C0919936 (UMLS CUI [2])
daily dose; screening; metformin; other; local; drug; day
Item
stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) other oad(s) allowed: sulphonylurea, glinides, pioglitazone, and dpp4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
boolean
C0935929 (UMLS CUI [1])
calcitonin; screening
Item
screening calcitonin greater than or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
estimated glomerular filtration rate <45ml/min/1.73m2; serum creatinine measurement; impairment; screening; renal; value; day; per
Item
renal impairment estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m2 as per ckd-epi value to be defined as listed in the classification ckd-epi using idms for serum creatinine measurement on the day of screening
boolean
C1565489 (UMLS CUI [1])
normal; liver; upper
Item
impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal
boolean
C0086565 (UMLS CUI [1])
thyroid; family; type
Item
family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
boolean
C0238462 (UMLS CUI [1])
C2956727 (UMLS CUI [2])
C2956727 (UMLS CUI [2])
pancreatitis; chronic; acute
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
concomitant medications; corticosteroids; glucose; thyroid; weight; affect
Item
anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
boolean
C2347852 (UMLS CUI [1])