A 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
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/2/2017 |
Start Date: | November 19, 2013 |
End Date: | May 14, 2014 |
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
This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and
insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)
system in adult subjects with type 1 diabetes.
trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and
insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)
system in adult subjects with type 1 diabetes.
Inclusion Criteria:
- Male or female, age at least 18 years at the time of signing inform consent
- Type 1 diabetes mellitus (diagnosed clinically) for at least 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 (glycosylated haemoglobin) below or equal to 9.0% as assessed by central
laboratory
- Body Mass Index (BMI) 20.0-35.0 kg/m^2
Exclusion Criteria:
- 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)
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials