DUAL™ II

CompletedPhase 3Results posted

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

A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

413

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

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 IDNCT01392573

Org study IDNN9068-3912

Secondary ID2011-002336-72

Secondary IDU1111-1121-4897WHO

Timeline

Milestones

Study first posted2011-07-12estimated

Study start2011-11-28actual

Primary completion2012-10-01actual

Study completion2012-10-04actual

Results first posted2017-01-20estimated

Last update posted2019-01-03actual

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 (glycosylated haemoglobin) 7.5-10.0% (both inclusive)

•Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)

•BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion criteria

•Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start

•Impaired liver function

•Impaired renal function

•Screening calcitonin equal to or above 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 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures

•Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)

•Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion

•History of chronic pancreatitis or idiopathic acute pancreatitis

Endpoints (4)

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
IDegLira	-2.7	—
IDeg	0.0	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

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	-1.90	—
IDeg	-0.89	—

Treatment contrast-1.0595% CI-1.25 – -0.84p<0.0001ANCOVA

Primary/protocol endpoint

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (7)

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 OLDER PATIENTS WITH TYPE 2 DIABETES.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2019 Feb (month)PMID30383495doi:10.4158/EP-2018-0284via 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
Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden.
Applied health economics and health policy2017 Apr (month)PMID28063135doi:10.1007/s40258-016-0301-yvia CT.gov background
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
Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).
Diabetes care2014 Nov (month)PMID25114296doi:10.2337/dc14-0785via 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.