Overview

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
Trial end date:
2014-05-14
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
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)