Brief Summary

This trial is conducted in Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

323

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Sep 2013

Geographic Reach

6 countries

58 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

1.2 years study duration

First Submitted

Initial submission to the registry

April 17, 2013

Completed

22 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

September 23, 2013

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2014

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed

Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

April 17, 2013

Results QC Date

October 2, 2017

Last Update Submit

May 28, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Week 0, week 18

Secondary Outcomes (5)

Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
After 18 weeks of randomised treatment
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
After 18 weeks of randomised treatment
Change From Baseline in Body Weight
Week 0, week 18
Number of Treatment Emergent Hypoglycaemic Episodes
Weeks 0-18
Number of Adverse Events
Weeks 0-18

Study Arms (2)

FIAsp and basal insulin + metformin

EXPERIMENTAL

Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.

Drug: Faster-acting insulin aspartDrug: basal insulin

Basal insulin + metformin

ACTIVE COMPARATOR

Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.

Drug: basal insulin

Interventions

Faster-acting insulin aspartDRUG

Administrated subcutaneously (s.c., under the skin) at each main meal.

Also known as: NN1218

FIAsp and basal insulin + metformin

basal insulinDRUG

Administrated subcutaneously (s.c., under the skin) once daily.

Basal insulin + metforminFIAsp and basal insulin + metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
Body mass index (BMI) equal or less than 40.0 kg/m\^2

You may not qualify if:

Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)

Contact the study team to confirm eligibility.