Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes (Onset® 5)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: Faster-acting insulin aspart

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02825251

U1111-1118-2480 (Other Identifier)

2010-024054-11 (EudraCT Number)

NL54555.018.16 (Other Identifier)

NN1218-3854

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 investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.

Enrollment

472 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 the informed consent
Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

Exclusion criteria

Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol