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

Key facts

Study ID

NCT02825251

Run by

Novo Nordisk A/S

People needed

472

Starts

2016-07-06

Expected to finish

2017-07-21

Last updated by the study team

2019-11-21

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 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Roseville, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — San Ramon, California, United States
• Novo Nordisk Investigational Site — Santa Barbara, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Newark, Delaware, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Arlington Heights, Illinois, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States
• Novo Nordisk Investigational Site — Nashua, New Hampshire, United States
• Novo Nordisk Investigational Site — Albany, New York, United States
• Novo Nordisk Investigational Site — Asheville, North Carolina, United States
• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Amarillo, Texas, United States
• Novo Nordisk Investigational Site — Austin, Texas, United States
• Novo Nordisk Investigational Site — Encino, California, United States

Full record on ClinicalTrials.gov

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