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

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 - onset® 4

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002233-37-DE

Enrollment

Registered

2013-09-17

Start date

2013-10-14

Completion date

Unknown

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1 MedDRA version: 16.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: FIAsp 3ml Penfill Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Concentration unit: U/ml unit(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female, age = 18 years at the time of signing inform consent - Type 1 diabetes mellitus (diagnosed clinically) = 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 = 9.0% as assessed by central laboratory - Body Mass Index (BMI) 20.0-35.0 kg/m^2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the compatibility of faster acting insulin aspart (FIAsp) and insulin aspart with the external continuous subcutaneous insulin (CSII) system over a 6-week treatment period.;Secondary Objective: To evaluate the treatment with FIAsp and insulin aspart with the external CSII system over a 6-week treatment period in terms of: - Safety - Additional compatibility endpoints;Primary end point(s): Number of microscopically confirmed episodes of infusion set occlusions ;Timepoint(s) of evaluation of this end point: During 6 weeks of treatment	—

Measure

Time frame

Main Objective: To evaluate the compatibility of faster acting insulin aspart (FIAsp) and insulin aspart with the external continuous subcutaneous insulin (CSII) system over a 6-week treatment period.;Secondary Objective: To evaluate the treatment with FIAsp and insulin aspart with the external CSII system over a 6-week treatment period in terms of: - Safety - Additional compatibility endpoints;Primary end point(s): Number of microscopically confirmed episodes of infusion set occlusions ;Timepoint(s) of evaluation of this end point: During 6 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Number of unexplained episodes of hyperglycaemia (confirmed by self-measured plasma glucose (SMPG)) 2. Number of episodes of possible infusion set occlusions 3. Number of premature infusion set changes ;Timepoint(s) of evaluation of this end point: 1.-3. During 6 weeks of treatment	—

Countries

Germany, United States

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026