Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

472

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jul 2016

Geographic Reach

9 countries

92 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

July 4, 2016

Completed

2 days until next milestone

Study Start

First participant enrolled

July 6, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2017

Completed

1 year until next milestone

Results Posted

Study results publicly available

July 24, 2018

Completed

Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

July 4, 2016

Results QC Date

June 27, 2018

Last Update Submit

November 12, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
Week 0, week 16

Secondary Outcomes (90)

Change From Baseline in 1-hour PPG Increment
Week 0, Week 16
Change From Baseline in 1,5-anhydroglucitol
Week 0, Week 16
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
Week 0, week 16
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 16
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
Week 16
+85 more secondary outcomes

Study Arms (2)

Faster-acting insulin aspart CSII

EXPERIMENTAL

Drug: Faster-acting insulin aspart

NovoRapid® CSII

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

Faster-acting insulin aspartDRUG

Injected s.c. /subcutaneously (under the skin)

Faster-acting insulin aspart CSII

insulin aspartDRUG

Injected s.c. /subcutaneously (under the skin)

NovoRapid® CSII

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.