DiabetesPhase 3DUAL™NCT02100475

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

A Phase 3 study testing insulin degludec/liraglutide and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 60 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec/liraglutide and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 60 sitesin 10 countries
Study dates: Apr 2014to Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

60 sites in 10 countries.

Country

City, postcode or hospital

60 sites in 10 countries

Russia11 sites

Novo Nordisk Investigational Site
Kazan', 420073
Novo Nordisk Investigational Site
Kirov, 610014
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 123448
Novo Nordisk Investigational Site
Novosibirsk, 630117
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Novo Nordisk Investigational Site
Tomsk, 634034
Novo Nordisk Investigational Site
Tomsk, 634041
Novo Nordisk Investigational Site
Volgograd, 400131

Other trials in Russia

Slovakia9 sites

Novo Nordisk Investigational Site
Bardejov, 08501
Novo Nordisk Investigational Site
Dolný Kubín, 02601
Novo Nordisk Investigational Site
Košice, 040 11
Novo Nordisk Investigational Site
Levice, 93401
Novo Nordisk Investigational Site
Poprad, 05801
Novo Nordisk Investigational Site
Považská Bystrica, 01701
Novo Nordisk Investigational Site
Prievidza, 97101
Novo Nordisk Investigational Site
Trnava, 91701
Novo Nordisk Investigational Site
Veľký Meder, 93201

Other trials in Slovakia

United States7 sites

Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33316-2521
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Gurnee, Illinois, 60031
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231

Other trials in United States

Spain6 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Valencia, 46026

Other trials in Spain

Argentina5 sites

Novo Nordisk Investigational Site
Buenos Aires, B1704ETD
Novo Nordisk Investigational Site
Capital Federal, C1056ABJ
Novo Nordisk Investigational Site
Corrientes, 3400
Novo Nordisk Investigational Site
Salta, 4400
Novo Nordisk Investigational Site
Zárate, B2800DGH

Other trials in Argentina

Australia5 sites

Novo Nordisk Investigational Site
East Ringwood, Victoria, 3135
Novo Nordisk Investigational Site
Herston, Queensland, 4029
Novo Nordisk Investigational Site
Ipswich, Queensland, 4305
Novo Nordisk Investigational Site
Robina, Queensland, 4226
Novo Nordisk Investigational Site
Wollongong, New South Wales, 2500

Other trials in Australia

Greece5 sites

Novo Nordisk Investigational Site
Athens, GR-11527
Novo Nordisk Investigational Site
Ioannina, 45500
Novo Nordisk Investigational Site
Larissa, GR-41110
Novo Nordisk Investigational Site
Thessaloniki, GR-54642
Novo Nordisk Investigational Site
Thessaloniki, GR-57001

Other trials in Greece

Hungary4 sites

Novo Nordisk Investigational Site
Eger, 3300
Novo Nordisk Investigational Site
Győr, 9024
Novo Nordisk Investigational Site
Gyula, 5700
Novo Nordisk Investigational Site
Miskolc, 3526

Other trials in Hungary

Mexico4 sites

Novo Nordisk Investigational Site
Cuernavaca, Morelos, 62250
Novo Nordisk Investigational Site
Mexico City, México, D.F., 03300
Novo Nordisk Investigational Site
Monterrey, 64460
Novo Nordisk Investigational Site
Pachuca, Hidalgo, 42084

Other trials in Mexico

South Africa4 sites

Novo Nordisk Investigational Site
Alberton, 1449
Novo Nordisk Investigational Site
Brits, North West, 0250
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4450
Novo Nordisk Investigational Site
Midrand, Gauteng, 1685

Other trials in South Africa

About this study

Official title: 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™ - Intensification)

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/liraglutide, insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02100475
Study group	Role	What they receive
Insulin degludec/liraglutide + Metformin	Experimental	Not described Receives: Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide + Insulin Aspart + Metformin	Active comparator	Not described Receives: Drug: insulin degludec/liraglutide; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of treatment.
Measured: Week 0, week 26
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).
Measured: Week 0 - 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Apr 2015

First posted1 Apr 2014 (estimated)
Study startApr 2014
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02100475
Sponsor's protocol ID: NN9068-4119
Other IDs: 2013-002878-47, U1111-1145-0183
Acronym: DUAL™
Status last verified: Nov 2016
First submitted: 27 Mar 2014
Last updated: 20 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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™ - Intensification)
ClinicalTrials.gov ID: NCT02100475
Acronym / sponsor ID: DUAL™ / NN9068-4119
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 1 Apr 2014 (estimated)
Results: Posted 20 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin degludec/liraglutide + Metformin	Experimental	Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide + Insulin Aspart + Metformin	Active comparator	Drug: insulin degludec/liraglutide, Drug: insulin aspart

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludec/liraglutideInsulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted.	Drug	Insulin degludec/liraglutide + Insulin Aspart + Metformin, Insulin degludec/liraglutide + Metformin
insulin aspartDose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.	Drug	Insulin degludec/liraglutide + Insulin Aspart + Metformin

Primary outcome

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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 20 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDegLira	16	14
IDegLira + IAsp	15	13

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: Percentage of glycosylated haemoglobin

Measure	IDegLira n = 16	IDegLira + IAsp n = 15
Value	-0.43 (0.94)	-0.14 (1.09)

IDegLira vs IDegLira + IAsp: Mean Difference (Final Values): -0.3 (95% CI -1.05 to 0.46), p = 0.427, ANCOVA

Population analysed: Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first trial-related activity (week 0) after the subject had signed the informed consent until the end of the post-treatment follow-up period (week 27).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegLira	1 of 16 (6.3%)	11 of 16 (68.8%)	Not reported
IDegLira + IAsp	2 of 15 (13.3%)	3 of 15 (20%)	Not reported

Limitations and caveats (from the sponsor): Due to the small number of subjects in this trial, the data should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

60 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/liraglutide and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Russia, Slovakia, United States, Spain, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02100475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.