NCT01814137|CompletedPhase 3Results

A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily

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Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-40032012-003152-37U1111-1132-2674

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredMar 2013

StartedMar 2013

CompletionMar 2014

Brief Summary

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Mar 2013

Geographic Reach

5 countries

40 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 year study duration

Study Start

First participant enrolled

March 1, 2013

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

November 13, 2015

Completed

Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

March 15, 2013

Results QC Date

October 14, 2015

Last Update Submit

February 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Incidence of Treatment Emergent Adverse Events (TEAEs)
During 26 weeks of treatment
Number of Treatment Emergent Hypoglycaemic Episodes
During 26 weeks of treatment
Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes
During 26 weeks of treatment
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26

Study Arms (2)

IDegAsp BID + IAsp OD

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: insulin aspart

IDeg OD + IAsp TID

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).

IDegAsp BID + IAsp OD

insulin degludecDRUG

For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).

IDeg OD + IAsp TID

insulin aspartDRUG

For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.

IDegAsp BID + IAsp OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

You may not qualify if:

Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females

Contact the study team to confirm eligibility.