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DiabetesPhase 3DUAL™ VNCT01952145

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing insulin degludec/liraglutide and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 91 sites in 10 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 globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus. 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 glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
557 participants
Where
91 sitesin 10 countries
Study dates
20 Sep 2013to 4 Nov 2014
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

Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) 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 (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic acute pancreatitis

Trial locations and contacts

91 sites in 10 countries.

91 sites in 10 countries

United States31 sites

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania, 16602

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Collierville, Tennessee, 38017

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80906

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Evansville, Indiana, 47725

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33316

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Los Alamitos, California, 90720

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Miami, Florida, 33165

  • Novo Nordisk Investigational Site

    Michigan City, Indiana, 46360

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73103

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Palm Springs, California, 92262

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33027

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19140

  • Novo Nordisk Investigational Site

    Renton, Washington, 98057

  • Novo Nordisk Investigational Site

    Saint Charles, Missouri, 63303

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    Slidell, Louisiana, 70461-4231

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99218

  • Novo Nordisk Investigational Site

    Tampa, Florida, 33603

  • Novo Nordisk Investigational Site

    West Jordan, Utah, 84088-8871

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

Russia12 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, 634041

  • Novo Nordisk Investigational Site

    Tomsk, 634050

  • Novo Nordisk Investigational Site

    Volgograd, 400131

  • Novo Nordisk Investigational Site

    Vsevolozhsk, 188643

Other trials in Russia

Slovakia11 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

    Košice, 04001

  • Novo Nordisk Investigational Site

    Levice, 93401

  • Novo Nordisk Investigational Site

    Ľubochňa, 03491

  • 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

Greece7 sites

  • Novo Nordisk Investigational Site

    Athens, GR-11527

  • Novo Nordisk Investigational Site

    Athens, GR-14233

  • 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-56403

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001

Other trials in Greece

Australia6 sites

  • Novo Nordisk Investigational Site

    Blacktown, New South Wales, 2148

  • 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

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

Hungary5 sites

  • Novo Nordisk Investigational Site

    Budapest, H-1134

  • 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

Mexico5 sites

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos, 62250

  • Novo Nordisk Investigational Site

    Durango, 34000

  • 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 Africa3 sites

  • Novo Nordisk Investigational Site

    Alberton, 1449

  • 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 the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.

Being tested
insulin degludec/liraglutide, insulin glargine
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 is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

  • insulin glargineDrug

    Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.

Study groups in NCT01952145
Study groupRoleWhat they receive
Insulin degludec/liraglutide OD plus metforminExperimentalNot described
Receives: Drug: insulin degludec/liraglutide
Insulin glargine OD plus metforminActive comparatorNot described
Receives: Drug: insulin glargine

What is being measured

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

  1. 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)

  1. Change From Baseline in Body Weight

    Change from baseline in body weight after 26 weeks of treatment

    Measured: Week 0, week 26

  2. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

    Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.

    Measured: During 26 weeks of treatment

Timeline

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

  1. First posted27 Sep 2013 (estimated)
  2. Study start20 Sep 2013
  3. Primary completion4 Nov 2014
  4. Study completion4 Nov 2014

Resources

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
557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952145
Sponsor's protocol ID
NN9068-3952
Other IDs
2012-004413-14, U1111-1135-1003
Acronym
DUAL™ V
Status last verified
Dec 2018
First submitted
24 Sep 2013
Last updated
3 Jan 2019
Data monitoring committee
No

Publications

  • Lingvay I, Perez Manghi F, Garcia-Hernandez P, Norwood P, Lehmann L, Tarp-Johansen MJ, Buse JB; DUAL V Investigators. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016 Mar 1;315(9):898-907. doi: 10.1001/jama.2016.1252.

    PubMed 26934259

  • Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the long-term cost-effectiveness of IDegLira versus liraglutide added to basal insulin for patients with type 2 diabetes failing to achieve glycemic control on basal insulin in the USA. J Med Econ. 2017 Jul;20(7):663-670. doi: 10.1080/13696998.2017.1301943. Epub 2017 Mar 15.

    PubMed 28294641

  • Hunt B, Mocarski M, Valentine WJ, Langer J. Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Continued Up-Titration of Insulin Glargine U100 in Patients with Type 2 Diabetes in the USA. Adv Ther. 2017 Apr;34(4):954-965. doi: 10.1007/s12325-017-0502-2. Epub 2017 Mar 9.

    PubMed 28281218

  • Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.

    PubMed 28417535

  • Lingvay I, Harris S, Jaeckel E, Chandarana K, Ranthe MF, Jodar E. Insulin degludec/liraglutide (IDegLira) was effective across a range of dysglycaemia and body mass index categories in the DUAL V randomized trial. Diabetes Obes Metab. 2018 Jan;20(1):200-205. doi: 10.1111/dom.13043. Epub 2017 Jul 31.

    PubMed 28643425

  • Psota M, Psenkova MB, Racekova N, Ramirez de Arellano A, Vandebrouck T, Hunt B. Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system. Clinicoecon Outcomes Res. 2017 Dec 12;9:749-762. doi: 10.2147/CEOR.S143127. eCollection 2017.

    PubMed 29276398

  • Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

    PubMed 30383495

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • Philis-Tsimikas A, Aroda VR, De Block C, Billings LK, Liebl A, Sivarathinasami R, D'Cruz JM, Lingvay I. Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes. J Diabetes Sci Technol. 2024 May;18(3):653-659. doi: 10.1177/19322968221149041. Epub 2023 Jan 29.

    PubMed 36710452

  • Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.

    PubMed 31705547

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec/liraglutide and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 91 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?

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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Russia, Slovakia, Greece, Australia 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 NCT01952145, which also lists 10 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 3 Jan 2019.

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