DUAL™IV

CompletedPhase 3Results posted

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

435

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-9%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01618162

Org study IDNN9068-3951

Secondary ID2012-000140-97

Secondary IDU1111-1126-9776WHO

Timeline

Milestones

Study first posted2012-06-13estimated

Study start2012-08-29actual

Primary completion2013-10-23actual

Study completion2013-10-23actual

Results first posted2017-02-17actual

Last update posted2017-10-27actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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)

•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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram	95% CI
IDegLira	0.5	—
Placebo	-1	—

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycosylated haemoglobin	95% CI
IDegLira	-1.45	—
Placebo	-0.46	—

Estimated treatment difference-1.0295% CI-1.18 – -0.87p< 0.001ANCOVA

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
IDegLira	79.2	—
Placebo	28.8	—

Secondary/registry result

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

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
IDegLira	64	—
Placebo	12.3	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
IDegLira	-2.6	—
Placebo	-0.31	—

Secondary/protocol endpoint

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), event rate per 100 PYE	95% CI
IDegLira	351.7	—
Placebo	135.2	—

Secondary/registry result

Number of Adverse Events (AEs)

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), event rate per 100 PYE	95% CI
IDegLira	401.4	—
Placebo	367	—

Secondary/protocol endpoint

Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Adverse Events (AEs)

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
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 therapy : research, treatment and education of diabetes and related disorders2017 Jun (month)PMID28332144doi:10.1007/s13300-017-0252-9via CT.gov background + pubmed nct search
Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with Type 2 diabetes: the DUAL IV trial.
Diabetic medicine : a journal of the British Diabetic Association2017 Feb (month)PMID27589252doi:10.1111/dme.13256via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.