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 (onset® 4)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: Faster-acting insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01999322

2013-002233-37 (EudraCT Number)

NN1218-3931

U1111-1143-2316 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups

FIAsp

Experimental group

Description:

The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period

Treatment:

Drug: Faster-acting insulin aspart

Insulin Aspart

Active Comparator group

Description:

The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period

Treatment:

Drug: insulin aspart