Brief Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

834

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2016

Typical duration for phase_3 diabetes

Geographic Reach

18 countries

155 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

1.8 years study duration

First Submitted

Initial submission to the registry

January 27, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

May 4, 2016

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed

26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 4, 2019

Completed

Last Updated

June 5, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

January 27, 2016

Results QC Date

January 30, 2019

Last Update Submit

May 22, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change in the Percentage of HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 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 participant-site contact and included data collected after a subject discontinued trial product.
Week 0, Week 26

Secondary Outcomes (79)

Change in 8-point SMPG Profile: Mean PPG Over All Three Meals
Week 0, Week 26
Change in 8-point SMPG Profile: PPG Increment Over All Three Meals
Week 0, Week 26
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG
Week 0, Week 26
Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment
Week 0, Week 26
Change in 8-point SMPG Profile: Mean of the 8-point Profile
Week 0, Week 26
+74 more secondary outcomes

Study Arms (3)

Meal-time faster-acting insulin aspart and insulin degludec

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: insulin degludec

Meal-time NovoRapid® (insulin aspart) and insulin degludec

ACTIVE COMPARATOR

Drug: insulin aspartDrug: insulin degludec

Post-meal faster-acting insulin aspart and insulin degludec

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: insulin degludec

Interventions

Faster-acting insulin aspartDRUG

For subcutaneous (s.c., under the skin) injection once daily.

Meal-time faster-acting insulin aspart and insulin degludecPost-meal faster-acting insulin aspart and insulin degludec

insulin aspartDRUG

For subcutaneous (s.c., under the skin) injection once daily.

Meal-time NovoRapid® (insulin aspart) and insulin degludec

insulin degludecDRUG

For subcutaneous (s.c., under the skin) injection once daily.

Meal-time NovoRapid® (insulin aspart) and insulin degludecMeal-time faster-acting insulin aspart and insulin degludecPost-meal faster-acting insulin aspart and insulin degludec

Eligibility Criteria

Age1 Year - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Contact the study team to confirm eligibility.