Informações:
Falhas:
ID
34290
Descrição
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01831765
Link
https://clinicaltrials.gov/show/NCT01831765
Palavras-chave
Versões (1)
- 16/01/2019 16/01/2019 -
Titular dos direitos
see on clinicaltrials.gov
Transferido a
16 de janeiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT01831765
Eligibility Diabetes NCT01831765
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT01831765
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
ID.1
Item
type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (visit 1)
boolean
ID.2
Item
currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (visit 1)
boolean
ID.3
Item
currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (visit 1)
boolean
ID.4
Item
hba1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
boolean
ID.5
Item
body mass index (bmi) below or equal to 35.0 kg/m^2
boolean
ID.6
Item
use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (visit 1)
boolean
ID.7
Item
recurrent severe hypoglycaemia (more than one 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 prior to screening (visit 1)
boolean
ID.8
Item
cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as stroke, decompensated heart failure new york heart association (nyha) class iii or iv, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
boolean