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.
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
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
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
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
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
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
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| Insulin degludec/liraglutide | Experimental | Not described Receives: Drug: insulin degludec/liraglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline to 26 weeks.
Measured: Week 0, Week 26
Secondary outcomes (6)
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
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
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG at week 26.
Measured: Week 0, week 26
Change From Baseline in Body Weight
Change from baseline in body weight at week 26.
Measured: Week 0, week 26
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:
- 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.
- 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
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.
- First posted13 Jun 2012 (estimated)
- Study start29 Aug 2012
- Primary completion23 Oct 2013
- Study completion23 Oct 2013
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 (3)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28332144Rodbard 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 27589252Natale 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01618162
- Acronym / sponsor ID
- DUAL™IV / NN9068-3951
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2012 (actual)
- Primary completion
- 23 Oct 2013 (actual)
- Study completion
- 23 Oct 2013 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 17 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec/liraglutide | Experimental | Drug: insulin degludec/liraglutide |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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/liraglutideInjected subcutaneously (under the skin) once daily. Dose individually adjusted. | Drug | Insulin degludec/liraglutide |
| placeboInjected subcutaneously (under the skin) once daily. | Drug | Placebo |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, Week 26
Change in HbA1c from baseline to 26 weeks.
6 secondary outcomes
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Time frame: Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time frame: Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Change From Baseline in Body Weight
Time frame: Week 0, week 26
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
Time frame: After 26 weeks of treatment
Number of Adverse Events (AEs)
Time frame: After 26 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28332144Khunti 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.
- Results publication: PubMed 27589252Rodbard 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.
- Derived from this study: PubMed 39963952Natale 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
87 sites in 8 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 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.