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DUAL™ V

CompletedPhase 3Results posted

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

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

91

Recruiting sites

—

Enrollment

557

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 IDNCT01952145
Org study IDNN9068-3952
Secondary ID2012-004413-14
Secondary IDU1111-1135-1003WHO

Timeline

Milestones

Study start2013-09-20actual
Study first posted2013-09-27estimated
Primary completion2014-11-04actual
Study completion2014-11-04actual
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

Eligibility criteria

•Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) 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 (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - 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) - History of chronic pancreatitis or idiopathic acute pancreatitis

Endpoints (6)

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
2
Glycemic / diabetes
2
Safety / tolerability / PK
2

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

GroupValue (mean), Kg95% CI
Insulin Degludec/Liraglutide (IDegLira)-1.4—
Insulin Glargine (IGlar)1.8—
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

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

GroupValue (mean), Percentage (%)95% CI
Insulin Degludec/Liraglutide (IDegLira)-1.81—
Insulin Glargine (IGlar)-1.13—
Treatment contrast-0.5995% CI-0.74 – -0.45p< 0.001ANCOVA

This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.

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

Safety / tolerability / PK

2 endpoints
Secondary/registry result

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

GroupValue (number), Number of episodes95% CI
Insulin Degludec/Liraglutide (IDegLira)289—
Insulin Glargine (IGlar)683—
Secondary/protocol endpoint

Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

Time frame:During 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Publications (11)

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

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.