DUAL™ VI

CompletedPhase 3Results posted

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

420

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 IDNCT02298192

Org study IDNN9068-4056

Secondary ID2012-004625-25

Secondary IDU1111-1135-6634WHO

Timeline

Milestones

Study first posted2014-11-21estimated

Study start2014-11-21actual

Primary completion2015-12-23actual

Study completion2015-12-23actual

Last update posted2017-05-23actual

Results first posted2017-05-23actual

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

•Type 2 diabetes mellitus

•Male or female equal to or above 18 years of age

•HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory

•Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening

•Body Mass Index (BMI) below or equal to 40 kg/m^2

Exclusion criteria

•Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)

•Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)

•Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit

•Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)

•Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin

•Screening calcitonin above or equal to 50 ng/L

•Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)

•History of pancreatitis (acute or chronic)

Endpoints (8)

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

Glycemic / diabetes

6 endpoints

Primary/registry result

Change From Baseline in HbA1c

Time frame:Week 0, week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
IDegLira (1WT)	-2.01	—
IDegLira	-2.02	—

Treatment Contrast0.1295% CI-0.04 – 0.28p0.012Mixed Models Analysis

The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.

Primary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Week 0, week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

HbA1c Below 7.0%

Time frame:Week 0, week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), participants	95% CI
IDegLira (1WT)yes	170	—
No	19	—
IDegLirayes	179	—
No	21	—

Secondary/registry result

HbA1c Below or Equal to 6.5%

Time frame:Week 0, week 32

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), particpants	95% CI
IDegLira (1WT)yes	158	—
No	31	—
IDegLirayes	170	—
No	30	—

Secondary/protocol endpoint

HbA1c Below 7.0%

Time frame:Week 0, week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Below or Equal to 6.5%

Time frame:Week 0, week 32

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-32

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
IDegLira (1WT)	20	—
IDegLira	97	—

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-32

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Publications (1)

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

Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial.
Diabetes, obesity & metabolism2017 Jun (month)PMID28124817doi:10.1111/dom.12892via 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.