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
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart (Drug); insulin aspart (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of microscopically confirmed episodes of infusion set occlusions
Secondary outcome: Number of unexplained episodes of hyperglycaemia (confirmed by self-measured plasma glucose (SMPG))Number of episodes of possible infusion set occlusions Number of premature infusion set changes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Neuss 41460, Germany
Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30318, United States
Additional Information
Clinical Trials at Novo Nordisk
Starting date: November 2013
Last updated: October 15, 2014
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