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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

Page last updated: August 23, 2015

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