Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,290

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2013

Typical duration for phase_3 diabetes

Geographic Reach

9 countries

191 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

April 11, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed

4 months until next milestone

Study Start

First participant enrolled

August 26, 2013

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2015

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed

Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

1.7 years

First QC Date

April 11, 2013

Results QC Date

October 2, 2017

Last Update Submit

May 28, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Week 0, week 26

Secondary Outcomes (7)

Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
Week 0, week 26
Change From Baseline in HbA1c (Post Meal Arm)
Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
From baseline until week 26
Change From Baseline in Body Weight
Week 0, week 26
Frequency of Adverse Events
After 52 weeks of randomised treatment
+2 more secondary outcomes

Study Arms (3)

Meal time FIAsp and insulin detemir

EXPERIMENTAL

Drug: Faster-acting insulin aspartDrug: insulin detemir

Meal time insulin aspart and insulin detemir

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Post meal FIAsp and insulin detemir

EXPERIMENTAL

Drug: insulin detemirDrug: Faster-acting insulin aspart

Interventions

Faster-acting insulin aspartDRUG

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.

Meal time FIAsp and insulin detemir

insulin detemirDRUG

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.

Meal time FIAsp and insulin detemirMeal time insulin aspart and insulin detemirPost meal FIAsp and insulin detemir

insulin aspartDRUG

Injected subcutaneously (s.c., under the skin), dose individually adjusted.

Meal time insulin aspart and insulin detemir

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.