DUAL™

CompletedPhase 3Results posted

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™ - Intensification)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02100475

Org study IDNN9068-4119

Secondary ID2013-002878-47

Secondary IDU1111-1145-0183WHO

Timeline

Milestones

Study first posted2014-04-01estimated

Last update posted2017-01-20estimated

Results first posted2017-01-20estimated

Study start2014-04 (month precision)

Primary completion2015-04actual (month precision)

Study completion2015-04actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin

•HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

Exclusion criteria

•Clinically significant diseases of the major organ systems

•Screening calcitonin above or equal to 50 ng/L

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

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	Mean · Kilograms	95% CI
IDegLira	0.9	-
IDegLira + IAsp	1.5	-

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

Group	Mean · Percentage of glycosylated haemoglobin	95% CI
IDegLira	-0.43	-
IDegLira + IAsp	-0.14	-

Mean difference (final values)-0.395% CI-1.05 - 0.46p0.427ANCOVA

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:Week 0 - 26

Documented hypoglycemia

event count, event

Posted result

Group	Number · Number of episodes	95% CI
IDegLira	34	-
IDegLira + IAsp	4	-

Secondary/protocol endpoint

Number of Treatment-emergent Confirmed Hypoglycaemic Episodes

Time frame:Week 0 - 26

Documented hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.