DiabetesPhase 3DUAL™ VINCT02298192

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

A Phase 3 study testing insulin degludec/liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 84 sites in 9 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial is conducted in Europe, North America and the United States of America. The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 420 participants
Where: 84 sitesin 9 countries
Study dates: 21 Nov 2014to 23 Dec 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

Type 2 diabetes mellitus
Male or female equal to or above 18 years of age
HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
Body Mass Index (BMI) below or equal to 40 kg/m^2

Who cannot join

Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
Screening calcitonin above or equal to 50 ng/L

Show all 9Show fewer

Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
History of pancreatitis (acute or chronic)

Trial locations and contacts

84 sites in 9 countries.

Country

City, postcode or hospital

84 sites in 9 countries

United States40 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Blackfoot, Idaho, 83221
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Chandler, Arizona, 85224
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80904
Novo Nordisk Investigational Site
Conyers, Georgia, 30094-5965
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, 41017-3464
Novo Nordisk Investigational Site
Glendale, Arizona, 85306-4652
Novo Nordisk Investigational Site
Glendale, Arizona, 85308
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hallandale, Florida, 33009
Novo Nordisk Investigational Site
Hamilton, Alabama, 35570
Novo Nordisk Investigational Site
Houston, Texas, 77008
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Katy, Texas, 77450
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89103
Novo Nordisk Investigational Site
Mesa, Arizona, 85213
Novo Nordisk Investigational Site
Miami, Florida, 33173
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Orlando, Florida, 32801
Novo Nordisk Investigational Site
Palm Springs, California, 92262
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Phoenix, Arizona, 85018
Novo Nordisk Investigational Site
Phoenix, Arizona, 85020
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, 78240
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Tucson, Arizona, 85741
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

Canada8 sites

Novo Nordisk Investigational Site
Burnaby, British Columbia, V5G 1T4
Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3K 2M5
Novo Nordisk Investigational Site
Liverpool, Nova Scotia, B0T 1K0
Novo Nordisk Investigational Site
London, Ontario, N6G 2M1
Novo Nordisk Investigational Site
Moncton, New Brunswick, E1G 1A7
Novo Nordisk Investigational Site
Surrey, British Columbia, V3S 2N6
Novo Nordisk Investigational Site
Waterloo, Ontario, N2J 1C4

Other trials in Canada

Austria7 sites

Novo Nordisk Investigational Site
Linz, 4021
Novo Nordisk Investigational Site
Mödling, 2340
Novo Nordisk Investigational Site
St. Stefan, 8511
Novo Nordisk Investigational Site
Vienna, 1010
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130
Novo Nordisk Investigational Site
Vienna, 1230

Other trials in Austria

Slovakia7 sites

Novo Nordisk Investigational Site
Bratislava, 81108
Novo Nordisk Investigational Site
Bratislava, 82102
Novo Nordisk Investigational Site
Bratislava, 851 01
Novo Nordisk Investigational Site
Dunajská Streda, 92901
Novo Nordisk Investigational Site
Sabinov, 08301
Novo Nordisk Investigational Site
Vranov nad Topľou, 09301
Novo Nordisk Investigational Site
Žilina, 01207

Other trials in Slovakia

Russia6 sites

Novo Nordisk Investigational Site
Barnaul, 656024
Novo Nordisk Investigational Site
Barnaul, 656045
Novo Nordisk Investigational Site
Cheboksary, 428000
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Samara, 443041

Other trials in Russia

Bulgaria5 sites

Novo Nordisk Investigational Site
Kozloduy, 3320
Novo Nordisk Investigational Site
Lukovit, 5770
Novo Nordisk Investigational Site
Rousse, 7000
Novo Nordisk Investigational Site
Sofia, 1784
Novo Nordisk Investigational Site
Varna, 9002

Other trials in Bulgaria

Czechia5 sites

Novo Nordisk Investigational Site
Olomouc, Lazce, 77900
Novo Nordisk Investigational Site
Pilsen, 30166
Novo Nordisk Investigational Site
Pilsen, 32600
Novo Nordisk Investigational Site
Prague, 140 46
Novo Nordisk Investigational Site
Trutnov, 541 01

Other trials in Czechia

Hungary5 sites

Novo Nordisk Investigational Site
Budapest, 1089
Novo Nordisk Investigational Site
Budapest, 1135
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Szombathely, H-9700
Novo Nordisk Investigational Site
Zalaegerszeg, 8900

Other trials in Hungary

Serbia1 site

Novo Nordisk Investigational Site
Belgrade, 11000

Other trials in Serbia

About this study

This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/liraglutide
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
For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Study groups in NCT02298192
Study group	Role	What they receive
Once weekly titration	Experimental	Not described Receives: Drug: insulin degludec/liraglutide
Twice weekly titration	Experimental	Not described Receives: Drug: insulin degludec/liraglutide

What is being measured

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

Change From Baseline in HbA1c
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
Measured: Week 0, week 32

Secondary outcomes (3)

HbA1c Below 7.0%
Responders to HbA1c below 7% after 32 weeks of treatment.
Measured: Week 0, week 32
HbA1c Below or Equal to 6.5%
Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.
Measured: Week 0, week 32
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Measured: Week 0-32

Timeline

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

21 Nov 201423 Dec 2015

First posted21 Nov 2014 (estimated)
Study start21 Nov 2014
Primary completion23 Dec 2015
Study completion23 Dec 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.
Publications (2)Papers the sponsor has linked to this study.
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: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02298192
Sponsor's protocol ID: NN9068-4056
Other IDs: 2012-004625-25, U1111-1135-6634
Acronym: DUAL™ VI
Status last verified: Apr 2017
First submitted: 19 Nov 2014
Last updated: 23 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Safety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016
Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.
PubMed 28124817

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 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms
ClinicalTrials.gov ID: NCT02298192
Acronym / sponsor ID: DUAL™ VI / NN9068-4056
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 21 Nov 2014 (actual)
Primary completion: 23 Dec 2015 (actual)
Study completion: 23 Dec 2015 (actual)
First posted: 21 Nov 2014 (estimated)
Results: Posted 23 May 2017

Clinical summary

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

This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Study design

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

Arm	Type	Receives
Once weekly titration	Experimental	Drug: insulin degludec/liraglutide
Twice weekly titration	Experimental	Drug: insulin degludec/liraglutide

Who may qualify

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

Key inclusion criteria (5 listed)

Type 2 diabetes mellitus
Male or female equal to or above 18 years of age
HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
Body Mass Index (BMI) below or equal to 40 kg/m^2

Key exclusion criteria (9 listed)

Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin

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/liraglutideFor subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.	Drug	Once weekly titration, Twice weekly titration

Primary outcome

Change From Baseline in HbA1c
Time frame: Week 0, week 32
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.

3 secondary outcomes

HbA1c Below 7.0%
Time frame: Week 0, week 32
HbA1c Below or Equal to 6.5%
Time frame: Week 0, week 32
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Week 0-32

Results and safety

Results posted to the registry on 23 May 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 (1WT)	210	191
IDegLira	210	204

Primary outcome: Change From Baseline in HbA1c

Time frame: Week 0, week 32. Mean (Standard Deviation). Unit: percentage

Measure	IDegLira (1WT) n = 189	IDegLira n = 200
Value	-2.01 (1.09)	-2.02 (0.98)

IDegLira (1WT) vs IDegLira: Treatment Contrast: 0.12 (95% CI -0.04 to 0.28), p = 0.012, Mixed Models Analysis

Population analysed: Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegLira (1WT)	7 of 209 (3.3%)	24 of 209 (11.5%)	Not reported
IDegLira	14 of 210 (6.7%)	19 of 210 (9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationSafety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016
Results publication: PubMed 28124817Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Active, not 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

84 sites in 9 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 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 84 sites in 9 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 5 inclusion and 9 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Canada, Austria, Slovakia, Russia and 4 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 23 May 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 (time frame: Week 0, week 32). 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 NCT02298192, which also lists 2 linked publications.

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 23 May 2017.