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

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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.


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
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Neuss,
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Atlanta, Georgia 30318
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Atlanta, GA
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