A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.

• Phase: Phase 1
• 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:

• Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)

• Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)

• Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)

• Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory

• Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Exclusion Criteria:

• History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)

• History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)

• Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)