Brief Summary

This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.

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

1,108

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2016

Geographic Reach

13 countries

152 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

1.3 years study duration

First Submitted

Initial submission to the registry

July 15, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed

10 months until next milestone

Study Start

First participant enrolled

May 4, 2016

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed

12 months until next milestone

Results Posted

Study results publicly available

August 10, 2018

Completed

Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

July 15, 2015

Results QC Date

July 16, 2018

Last Update Submit

May 28, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c 26 Weeks After Randomisation
Change from baseline (week 0) in 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 subject-site contact.
Week 0, week 26

Secondary Outcomes (48)

Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)
Week 0, week 26
Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation
Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation
Week 0, week 26
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation
26 weeks after randomisation
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation
26 weeks after randomisation
+43 more secondary outcomes

Study Arms (3)

Mealtime faster-acting insulin aspart and insulin degludec

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: insulin degludec

Mealtime NovoRapid® and insulin degludec

ACTIVE COMPARATOR

Drug: insulin aspartDrug: insulin degludec

Postmeal faster-acting insulin aspart and insulin degludec

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: insulin degludec

Interventions

Faster-acting insulin aspartDRUG

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

Mealtime faster-acting insulin aspart and insulin degludecPostmeal faster-acting insulin aspart and insulin degludec

insulin aspartDRUG

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

Mealtime NovoRapid® and insulin degludec

insulin degludecDRUG

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Mealtime NovoRapid® and insulin degludecMealtime faster-acting insulin aspart and insulin degludecPostmeal faster-acting insulin aspart and insulin degludec

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.