Phase 3
Completed N=37
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
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01999322 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Number of Microscopically Confirmed Episodes of Infusion Set Occlusions — 0; 0 Episodes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Microscopically Confirmed Episodes of Infusion Set Occlusions |
0; 0 | — |
| SECONDARY Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG)) |
28; 16 | — |
| SECONDARY Number of Episodes of Possible Infusion Set Occlusions |
7; 0 | — |
| SECONDARY Number of Premature Infusion Set Changes |
21; 4 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01999322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.