ID

33741

Descrizione

A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02147431

collegamento

https://clinicaltrials.gov/show/NCT02147431

Keywords

versioni (1)
  1. 21/12/18 21/12/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

21 dicembre 2018

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.

Torna ai commenti del modello
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 NCT02147431

Inglese

Eligibility Diabetes NCT02147431

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02147431
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. stable is defined as unchanged dose
Descrizione

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
male or female, age between18-64 years (both inclusive) at the time of signing informed consent
Descrizione

Age | Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
hba1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)
Descrizione

Hemoglobin A1c measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. an exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
Descrizione

Hypoglycemic Agents | Exception Metformin | Exception Insulin Comorbidity Related

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0009488
UMLS CUI [3,4]
C0439849
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Descrizione

Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0011880
blood or plasma donation within the past month or more than 500 ml within the last 3 months prior to first semaglutide dosing
Descrizione

Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount | Status pre- Semaglutide Dose

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0005794
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C3885068
UMLS CUI [5,3]
C0178602
Ritorna all'inizio della pagina

Similar models

Eligibility Diabetes NCT02147431

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02147431
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable
Item
subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. stable is defined as unchanged dose
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Age | Informed Consent
Item
male or female, age between18-64 years (both inclusive) at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Metformin | Exception Insulin Comorbidity Related
Item
treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. an exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0009488 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0011880 (UMLS CUI [3,2])
Blood Donation | Plasma Donation | Blood Donation Amount | Plasma Donation Amount | Status pre- Semaglutide Dose
Item
blood or plasma donation within the past month or more than 500 ml within the last 3 months prior to first semaglutide dosing
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0005794 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0332152 (UMLS CUI [5,1])
C3885068 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
Ritorna all'inizio della pagina 

Contatto

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

I campi contrassegnati da * sono obbligatori.

Aiuto

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