DUAL™ I

CompletedPhase 3Results posted

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

302

Recruiting sites

—

Enrollment

1,663

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT01336023

Org study IDNN9068-3697

Secondary ID2010-021560-15

Secondary IDU1111-1119-1174WHO

Timeline

Milestones

Study first posted2011-04-15estimated

Study start2011-05-23actual

Primary completion2012-05-24actual

Study completion2012-11-22actual

Results first posted2017-06-02actual

Last update posted2018-02-19actual

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

•HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%

•Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)

•Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated dose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening

•Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion criteria

•Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)

•Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial

•Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)

•Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)

•Screening calcitonin at least 50 ng/L

•Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)

•Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures

•Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)

•Acute treatment required proliferative retinopathy or maculopathy (macular oedema)

•History of chronic pancreatitis or idiopathic acute pancreatitis

Endpoints (10)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Mean Change From Baseline in Body Weight at Week 26

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
IDeg	1.6	—
IDegLira	-0.5	—
Liraglutide	-3.0	—

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at Week 26

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

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
IDeg	-1.44	—
IDegLira	-1.91	—
Liraglutide	-1.28	—

Treatment Contrast-0.4795% CI-0.58 – -0.36ANCOVA

Treatment contrast-0.6495% CI-0.75 – -0.53ANCOVA

Primary/protocol endpoint

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
IDeg	-0.17	—
IDegLira	-0.87	—
Liraglutide	-0.78	—

Secondary/registry result

Mean Actual Daily Insulin Dose

Time frame:Week 26

descriptive

Posted result

Group	Value (mean), units	95% CI
IDeg	53	—
IDegLira	38	—

Secondary/protocol endpoint

Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean Actual Daily Insulin Dose

Time frame:Week 26

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Events per 100 patient years of exposure	95% CI
IDeg	256.7	—
IDegLira	180.2	—
Liraglutide	22.0	—

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Publications (9)

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
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, obesity & metabolism2017 Nov (month)PMID28417535doi:10.1111/dom.12972via CT.gov reference
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
A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges.
Diabetes technology & therapeutics2017 Apr (month)PMID28282219doi:10.1089/dia.2016.0405via CT.gov reference + pubmed nct search
Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone.
Clinical drug investigation2016 Apr (month)PMID26894800doi:10.1007/s40261-016-0376-0via CT.gov reference
Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy.
Journal of clinical pharmacology2015 Dec (month)PMID25998481doi:10.1002/jcph.549via CT.gov reference
IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test.
Journal of diabetes science and technology2015 Oct 6PMID26443290doi:10.1177/1932296815610124via CT.gov reference + pubmed nct search
One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
Diabetes, obesity & metabolism2015 Oct (month)PMID25980900doi:10.1111/dom.12498via CT.gov reference
Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.
The lancet. Diabetes & endocrinology2014 Nov (month)PMID25190523doi:10.1016/S2213-8587(14)70174-3via CT.gov reference + pubmed nct search

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.