NCT02100475|CompletedPhase 3Results

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

DUAL™

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-41192013-002878-47U1111-1145-0183

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredApr 2014

StartedApr 2014

CompletionApr 2015

Brief Summary

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

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 Apr 2014

Geographic Reach

10 countries

60 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

First Submitted

Initial submission to the registry

March 27, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed

Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed

Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

March 27, 2014

Results QC Date

November 23, 2016

Last Update Submit

November 23, 2016

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 (2)

Change From Baseline in Body Weight
Week 0, week 26
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
Week 0 - 26

Study Arms (2)

Insulin degludec/liraglutide + Metformin

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Insulin degludec/liraglutide + Insulin Aspart + Metformin

ACTIVE COMPARATOR

Drug: insulin degludec/liraglutideDrug: insulin aspart

Interventions

insulin degludec/liraglutideDRUG

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted.

Insulin degludec/liraglutide + Insulin Aspart + MetforminInsulin degludec/liraglutide + Metformin

insulin aspartDRUG

Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Insulin degludec/liraglutide + Insulin Aspart + Metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

You may not qualify if:

Clinically significant diseases of the major organ systems
Screening calcitonin above or equal to 50 ng/L

Contact the study team to confirm eligibility.