A 6-week randomised, double-blind, parallel-group trial evaluating compatibility and safety of FIAsp and insulin aspart with an external continuous subcutaneous insulin infusion system in adult subjects with type 1 diabetes - onset® 4

ovo Nordisk A/S0 个研究点目标入组 36 人开始时间: 2013年9月17日最近更新: 2015年3月23日

适应症

试验速览

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•- Male or female, age = 18 years at the time of signing inform consent
•- Type 1 diabetes mellitus (diagnosed clinically) = 12 months at the time of screening (Visit 1)
•- Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
•- Using an external CSII system for the previous 6 months prior to screening (Visit 1)
•- HbA1c = 9.0% as assessed by central laboratory
•- Body Mass Index (BMI) 20.0-35.0 kg/m^2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•- History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
•- History of abscess at the infusion site within 6 months prior to screening (Visit 1)
•- Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (Visit 1)

发起方