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DiabetesPhase 3DUAL™IVNCT01618162

The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

A Phase 3 study testing insulin degludec/liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 87 sites in 8 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 Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. 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?
Yes, some participants may receive a placebo
How many people
435 participants
Where
87 sitesin 8 countries
Study dates
29 Aug 2012to 23 Oct 2013
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

  • Subjects with type 2 diabetes mellitus
  • HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
  • Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
  • Body Mass Index (BMI) below or equal to 40 kg/m^2

Who cannot join

  • Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
  • Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
  • Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
  • Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
  • 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)
Show all 10Show fewer
  • Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
  • Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
  • Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product
  • History of chronic pancreatitis or idiopathic acute pancreatitis

Trial locations and contacts

87 sites in 8 countries.

87 sites in 8 countries

United States44 sites
  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30318

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45220-2213

  • Novo Nordisk Investigational Site

    Crestview Hills, Kentucky, 41017-3464

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75203

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75251

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Garden Grove, California, 92844

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Hurst, Texas, 76054

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34741

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Lodi, New Jersey, 076444

  • Novo Nordisk Investigational Site

    Long Beach, California, 90807

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Mason, Ohio, 45040-6815

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32934

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83646

  • Novo Nordisk Investigational Site

    Miami, Florida, 33136

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire, 03063

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37203

  • Novo Nordisk Investigational Site

    Newport News, Virginia, 23606

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104-5020

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina, 29669

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19152

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23219

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Saint Charles, Missouri, 63303

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84107

  • Novo Nordisk Investigational Site

    San Mateo, California, 94401

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina, 29681

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina, 29303

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Tabor City, North Carolina, 28463

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

Other trials in United States

Canada10 sites
  • Novo Nordisk Investigational Site

    Burnaby, British Columbia, V5G 1T4

  • Novo Nordisk Investigational Site

    Cambridge, Ontario, N1R 7L6

  • Novo Nordisk Investigational Site

    London, Ontario, N6G 2M1

  • Novo Nordisk Investigational Site

    Mirabel, Quebec, J7J 2K8

  • Novo Nordisk Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • Novo Nordisk Investigational Site

    Québec, G1N 4V3

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec, J1G 5K2

  • Novo Nordisk Investigational Site

    Surrey, British Columbia, V3S 2N6

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M4S 1Y2

  • Novo Nordisk Investigational Site

    Victoria, British Columbia, V8V 3N7

Other trials in Canada

India8 sites
  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560043

  • Novo Nordisk Investigational Site

    Belagavi, Karnataka, 590001

  • Novo Nordisk Investigational Site

    Delhi, New Delhi, 110002

  • Novo Nordisk Investigational Site

    Guwahati, Assam, 781007

  • Novo Nordisk Investigational Site

    Guwahati, Assam

  • Novo Nordisk Investigational Site

    Hyderabad, 600034

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400008

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411030

Other trials in India

Germany7 sites
  • Novo Nordisk Investigational Site

    Esslingen am Neckar, 73728

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Pohlheim, 35415

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Israel7 sites
  • Novo Nordisk Investigational Site

    Haifa, 35152

  • Novo Nordisk Investigational Site

    Holon, 58100

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Kfar Saba, 44281

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

  • Novo Nordisk Investigational Site

    Tel Aviv, 64239

  • Novo Nordisk Investigational Site

    Tel HaShomer, 52621

Other trials in Israel

Bulgaria5 sites
  • Novo Nordisk Investigational Site

    Lukovit, 5770

  • Novo Nordisk Investigational Site

    Rousse, 7000

  • Novo Nordisk Investigational Site

    Sofia, 1324

  • Novo Nordisk Investigational Site

    Sofia, 1431

  • Novo Nordisk Investigational Site

    Sofia, 1606

Other trials in Bulgaria

Turkey (Türkiye)5 sites
  • Novo Nordisk Investigational Site

    Ankara, 06110

  • Novo Nordisk Investigational Site

    Antalya, 07058

  • Novo Nordisk Investigational Site

    Gaziantep, 27070

  • Novo Nordisk Investigational Site

    Istanbul, 34752

  • Novo Nordisk Investigational Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Puerto Rico1 site
  • Novo Nordisk Investigational Site

    Manati, 00674

Other trials in Puerto Rico

About this study

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Being tested
insulin degludec/liraglutide, placebo
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

    Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

  • placeboDrug

    Injected subcutaneously (under the skin) once daily.

Study groups in NCT01618162
Study groupRoleWhat they receive
Insulin degludec/liraglutideExperimentalNot described
Receives: Drug: insulin degludec/liraglutide
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Change in HbA1c from baseline to 26 weeks.

    Measured: Week 0, Week 26

Secondary outcomes (6)
  1. Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

    Percentage of subjects having HbA1c below 7% at week 26.

    Measured: Week 26

  2. Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

    Percentage of subjects having HbA1c below 6.5% at week 26

    Measured: Week 26

  3. Change From Baseline in Fasting Plasma Glucose (FPG)

    Change from baseline in FPG at week 26.

    Measured: Week 0, week 26

  4. Change From Baseline in Body Weight

    Change from baseline in body weight at week 26.

    Measured: Week 0, week 26

  5. Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes

    An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.

    Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.

    Minor hypoglycaemic episodes were defined as:

    1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.
    2. Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).

    Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).

    Measured: After 26 weeks of treatment

  6. Number of Adverse Events (AEs)

    An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.

    Measured: After 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 posted13 Jun 2012 (estimated)
  2. Study start29 Aug 2012
  3. Primary completion23 Oct 2013
  4. Study completion23 Oct 2013

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
Double blind
Who is masked
Participant, Investigator
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01618162
Sponsor's protocol ID
NN9068-3951
Other IDs
2012-000140-97, U1111-1126-9776
Acronym
DUAL™IV
Status last verified
Sep 2017
First submitted
11 Jun 2012
Last updated
27 Oct 2017
Data monitoring committee
No

Publications

  • Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.

    PubMed 28332144
  • Rodbard HW, Bode BW, Harris SB, Rose L, Lehmann L, Jarlov H, Thurman J; Dual Action of Liraglutide and insulin degludec (DUAL) IV trial investigators. Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naive people with Type 2 diabetes: the DUAL IV trial. Diabet Med. 2017 Feb;34(2):189-196. doi: 10.1111/dme.13256. Epub 2016 Oct 7.

    PubMed 27589252
  • 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

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 87 sites in 8 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 4 inclusion and 10 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada, India, Germany, Israel and 3 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. Some participants in this study may receive a placebo. 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 17 Feb 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 in Glycosylated Haemoglobin (HbA1c) (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 NCT01618162, which also lists 3 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 27 Oct 2017.

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