Brief Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 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

881

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2013

Typical duration for phase_3 diabetes

Geographic Reach

10 countries

144 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

March 21, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed

6 months until next milestone

Study Start

First participant enrolled

September 9, 2013

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2015

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

December 5, 2017

Completed

Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

March 21, 2013

Results QC Date

October 2, 2017

Last Update Submit

January 10, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c
The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Week 0, Week 26

Secondary Outcomes (3)

Change From Baseline in 2-hour PPG Increment (Meal Test)
Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
From Week 0 to Week 26.
Change From Baseline in Body Weight
Week 0, week 26

Study Arms (2)

Faster-acting insulin aspart (FIAsp)

EXPERIMENTAL

Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Drug: Faster-acting insulin aspartDrug: Insulin glargine

Insulin aspart

ACTIVE COMPARATOR

Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Drug: Insulin aspartDrug: Insulin glargine

Interventions

Faster-acting insulin aspartDRUG

Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Faster-acting insulin aspart (FIAsp)

Insulin aspartDRUG

Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin aspart

Insulin glargineDRUG

Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Faster-acting insulin aspart (FIAsp)Insulin aspart

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.