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Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes | Clinical Trials | Clareo Health

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

NCT02825251•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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
•Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol

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

Locations (92)

Novo Nordisk Investigational Site

Encino, California, United States

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

Key Dates

Start Date

July 6, 2016

Primary Completion Date

June 20, 2017

Completion Date

July 21, 2017

Last Updated

November 21, 2019

Enrollment

472

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1

Interventions

Faster-acting insulin aspart

DRUG

insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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