DUAL™ III

CompletedPhase 3Results posted

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

Lead sponsor

Novo Nordisk A/S

Assets

Exenatide / GLP-1 / incretin class catch-all / Liraglutide

Listed sites

109

Recruiting sites

—

Enrollment

438

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c 7-9%

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 IDNCT01676116

Org study IDNN9068-3851

Secondary ID2012-000209-63

Secondary IDU1111-1127-1321WHO

Timeline

Milestones

Study start2012-08-29actual

Study first posted2012-08-30estimated

Primary completion2014-03-11actual

Study completion2014-03-11actual

Results first posted2018-07-09actual

Last update posted2019-01-03actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all 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 mellitus

•Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)

•Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)

•BMI (body mass index) equal to or below 40 kg/m^2

Exclusion criteria

•Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)

•Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)

•Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)

•Screening calcitonin equal to or above 50 ng/l

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

•Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures

•Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion

•Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products

•History of chronic pancreatitis or idiopathic acute pancreatitis

Endpoints (18)

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

Patient-reported / QoL

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	Value (mean), kg	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	2	—
Liraglutide or Exenatide + OADs	-0.8	—

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

8 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated haemoglobin	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	-1.32	—
Liraglutide or Exenatide + OADs	-0.37	—

Treatment contrast-0.9495% CI-1.11 – -0.78p<0.001ANCOVA

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	75.3	—
Liraglutide or Exenatide + OADs	35.6	—

Secondary/registry result

Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	63	—
Liraglutide or Exenatide + OADs	22.6	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	-2.98	—
Liraglutide or Exenatide + OADs	-0.6	—

Secondary/protocol endpoint

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)TRIM-D Treatment Burden Score	10.8	—
TRIM-D Daily Life Score	6.3	—
TRIM-D Diabetes Management Score	10.9	—
TRIM-D Compliance Score	8.9	—
TRIM-D Psychological Health Score	7.3	—
TRIM-D Total Score	8.7	—
Liraglutide or Exenatide + OADsTRIM-D Treatment Burden Score	5.7	—
TRIM-D Daily Life Score	0.8	—
TRIM-D Diabetes Management Score	4.1	—
TRIM-D Compliance Score	4.3	—
TRIM-D Psychological Health Score	1.4	—
TRIM-D Total Score	3.1	—

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)Treatment satisfaction scale total	3.1	—
Hyperglycaemia	-1.8	—
Hypoglycaemia	0.2	—
Liraglutide or Exenatide + OADsTreatment satisfaction scale total	1.1	—
Hyperglycaemia	-0.6	—
Hypoglycaemia	-0.1	—

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Time frame:Week 0, week 26

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Severe or Minor Hypoglycaemic Episodes

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), events per 100 patient years of exposure	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	281.7	—
Liraglutide or Exenatide + OADs	12.1	—

Secondary/registry result

Number of Adverse Events (AEs)

Time frame:After 26 weeks of treatment

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events per 100 exposure years	95% CI
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)	410.1	—
Liraglutide or Exenatide + OADs	364.3	—

Secondary/protocol endpoint

Number of Severe or Minor Hypoglycaemic Episodes

Time frame:After 26 weeks of treatment

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Adverse Events (AEs)

Time frame:After 26 weeks of treatment

Treatment-emergent AEs (any)

event count, event

Publications (3)

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
The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial.
Diabetes therapy : research, treatment and education of diabetes and related disorders2017 Feb (month)PMID27943107doi:10.1007/s13300-016-0218-3via 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.