Informatie:
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ID
11999
Beschrijving
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01984606
Link
https://clinicaltrials.gov/show/NCT01984606
Trefwoorden
Versies (1)
- 31-08-15 31-08-15 -
Houder van rechten
ODM derived from: https://clinicaltrials.gov/show/NCT01984606
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31 augustus 2015
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01984606
Eligibility Diabetes Mellitus, Type 2 NCT01984606
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01984606
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
diabetes mellitus; type 2 diabetes; diagnosis
Item
diagnosis of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
exercise; regimen; female; diet
Item
male and female patients on diet and exercise regimen who are:
boolean
C0682069 (UMLS CUI [1])
treatment; therapy; oral
Item
treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
boolean
C0039798 (UMLS CUI [1])
metformin; local; dose; day
Item
pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. minimum dose for metformin: >=1500 mg/day or maximum tolerated dose or maximum dose according to local label.
boolean
C0025598 (UMLS CUI [1])
visit; hba1c
Item
hba1c of >= 7.5 % and <= 10.5 % at visit 1 and 3.
boolean
C0019018 (UMLS CUI [1])
age
Item
age >= 18 yrs.
boolean
C0001779 (UMLS CUI [1])
glucose; mmol/l; dose
Item
uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15 mmol/l) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
boolean
C0020456 (UMLS CUI [1])
treatment; other; drug
Item
any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
boolean
C0935929 (UMLS CUI [1])
treatment; metformin; other; drug
Item
any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
boolean
C0935929 (UMLS CUI [1])
acute coronary syndrome; informed consent; unstable angina; angina pectoris; stroke; stemi; non
Item
acute coronary syndrome (non-stemi, stemi and unstable angina pectoris), stroke or tia within 3 months prior to informed consent.
boolean
C0948089 (UMLS CUI [1])
liver disease; indication
Item
indication of liver disease.
boolean
C0023895 (UMLS CUI [1])
impairment; moderate; severe; renal
Item
moderate to severe renal impairment.
boolean
C1565489 (UMLS CUI [1])
surgery
Item
bariatric surgery within the past two years.
boolean
C1456587 (UMLS CUI [1])
informed consent; treatment; obesity; drugs
Item
treatment with anti-obesity drugs 3 months prior to informed consent.
boolean
C0376607 (UMLS CUI [1])
diabetes mellitus; informed consent; type 2 diabetes; treatment; steroids; disorder; other; systemic; current; time
Item
current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
boolean
C2825233 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0014130 (UMLS CUI [2])