ID

12004

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02501161

Keywords

versioni (2)
  1. 31/08/15 31/08/15 -
  2. 08/02/18 08/02/18 - Julian Varghese
Titolare del copyright

ODM derived from: https://clinicaltrials.gov/show/NCT02501161

Caricato su

31 agosto 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Diabetes NCT02501161

Inglese

Eligibility Diabetes NCT02501161

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02501161
Inclusion Criteria
Descrizione

Inclusion Criteria

male or female, age greater than or equal to 18 years at the time of signing informed consent
Descrizione

age greater than or equal to 60 years; informed consent; female; time

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0682069
subjects diagnosed with type 2 diabetes mellitus
Descrizione

diagnosed with type 2 diabetes mellitus.; patients with type 2 diabetes

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
Descrizione

laboratory; hba1c; both

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019018
body mass index greater than or equal to 20 kg/m^2
Descrizione

body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
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
Descrizione

treatment; screening; diabetes; insulin; day

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0919936
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)
Descrizione

daily dose; screening; metformin; other; local; drug; day

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0935929
Exclusion Criteria
Descrizione

Exclusion Criteria

screening calcitonin greater than or equal to 50 ng/l
Descrizione

calcitonin; screening

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201924
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
Descrizione

estimated glomerular filtration rate <45ml/min/1.73m2; serum creatinine measurement; impairment; screening; renal; value; day; per

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
impaired liver function, defined as alat or asat greater than or equal to 2.5 times upper limit of normal
Descrizione

normal; liver; upper

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
Descrizione

thyroid; family; type

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C2956727
history of pancreatitis (acute or chronic)
Descrizione

pancreatitis; chronic; acute

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0030305
Inclusion Criteria
Descrizione

Inclusion Criteria

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)
Descrizione

concomitant medications; corticosteroids; glucose; thyroid; weight; affect

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852
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Similar models

Eligibility Diabetes NCT02501161

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02501161
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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])
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])
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])
Ritorna all'inizio della pagina 

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