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)