ID

11999

Descrizione

Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01984606

collegamento

https://clinicaltrials.gov/show/NCT01984606

Keywords

  1. 31/08/15 31/08/15 -
Titolare del copyright

ODM derived from: https://clinicaltrials.gov/show/NCT01984606

Caricato su

31 agosto 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Diabetes Mellitus, Type 2 NCT01984606

Eligibility Diabetes Mellitus, Type 2 NCT01984606

Inclusion Criteria
Descrizione

Inclusion Criteria

Inclusion Criteria
Descrizione

Inclusion Criteria

diagnosis of type 2 diabetes mellitus.
Descrizione

diabetes mellitus; type 2 diabetes; diagnosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011860
male and female patients on diet and exercise regimen who are:
Descrizione

exercise; regimen; female; diet

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0682069
treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
Descrizione

treatment; therapy; oral

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0039798
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.
Descrizione

metformin; local; dose; day

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0025598
hba1c of >= 7.5 % and <= 10.5 % at visit 1 and 3.
Descrizione

visit; hba1c

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019018
age >= 18 yrs.
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrizione

Exclusion Criteria

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.
Descrizione

glucose; mmol/l; dose

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020456
any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
Descrizione

treatment; other; drug

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0935929
any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
Descrizione

treatment; metformin; other; drug

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0935929
acute coronary syndrome (non-stemi, stemi and unstable angina pectoris), stroke or tia within 3 months prior to informed consent.
Descrizione

acute coronary syndrome; informed consent; unstable angina; angina pectoris; stroke; stemi; non

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948089
indication of liver disease.
Descrizione

liver disease; indication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
moderate to severe renal impairment.
Descrizione

impairment; moderate; severe; renal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1565489
bariatric surgery within the past two years.
Descrizione

surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1456587
treatment with anti-obesity drugs 3 months prior to informed consent.
Descrizione

informed consent; treatment; obesity; drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0376607
current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
Descrizione

diabetes mellitus; informed consent; type 2 diabetes; treatment; steroids; disorder; other; systemic; current; time

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0014130

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01984606

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial