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
Completed · Phase 3
Conditions studied: Diabetes, Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT01999322
- Run by
- Novo Nordisk A/S
- People needed
- 37
- Starts
- 2013-11-19
- Expected to finish
- 2014-05-14
- Last updated by the study team
- 2017-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Novo Nordisk Investigational Site — Atlanta, Georgia, United States
- Novo Nordisk Investigational Site — Neuss, Germany
Full record on ClinicalTrials.gov
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