GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02420262

CompletedPhase 3Results posted

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

117

Recruiting sites

—

Enrollment

506

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 IDNCT02420262

Org study IDNN9068-4185

Secondary ID2014-003621-18

Secondary IDREec-2015-1682Spanish registry

Secondary IDU1111-1160-6923WHO

Timeline

Milestones

Study first posted2015-04-17estimated

Study start2015-07-26actual

Primary completion2016-10-05actual

Study completion2016-10-05actual

Results first posted2017-12-07actual

Last update posted2018-03-29actual

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

•Male or female, age at least 18 years at the time of signing informed consent

•Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

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

•Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening

•Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive

•Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening

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

Exclusion criteria

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening

•Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)

•Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal

•Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)

•Screening calcitonin at least 50 ng/L

•History of pancreatitis (acute or chronic)

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Endpoints (10)

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

Weight & body composition

Safety / tolerability / PK

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 (least_squares_mean), kg	95% CI
IDegLira	-0.93	—
IGlar + IAsp	2.64	—

Treatment difference-3.5795% CI-4.19 – -2.95p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change in HbA1c (Glycosylated Haemoglobin)

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
IDegLira	-1.48	—
IGlar + IAsp	-1.46	—

Treatment contrast-0.0295% CI-0.16 – 0.12p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Responder for HbA1c Below 7.0%

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
IDegLiraYes	157	—
No	81	—
IGlar + IAspYes	156	—
No	77	—

Secondary/registry result

Responder for HbA1c Below or Equal to 6.5 %

Time frame:After 26 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
IDegLiraYes	118	—
No	120	—
IGlar + IAspYes	104	—
No	129	—

Secondary/protocol endpoint

Responder for HbA1c Below 7.0%

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder for HbA1c Below or Equal to 6.5 %

Time frame:After 26 weeks of treatment

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 Confirmed Symptomatic Hypoglycaemic Episodes.

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
IDegLira	129	—
IGlar + IAsp	975	—

Treatment ratio0.1195% CI0.08 – 0.17p<0.0001Negative binomial regression model

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Publications (5)

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

The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial.
Journal of diabetes science and technology2021 May (month)PMID32107930doi:10.1177/1932296820906888via clinicaltrials gov reference derived + pubmed nct search
Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin.
Diabetic medicine : a journal of the British Diabetic Association2020 Feb (month)PMID31705547doi:10.1111/dme.14178via clinicaltrials gov reference derived + pubmed nct search
Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets.
Journal of managed care & specialty pharmacy2020 Feb (month)PMID31856636doi:10.18553/jmcp.2019.19035via pubmed nct search
Cost of achieving HbA1c and weight loss treatment targets with IDegLira vs insulin glargine U100 plus insulin aspart in the USA.
ClinicoEconomics and outcomes research : CEOR2019 (year)PMID30962697doi:10.2147/CEOR.S194719via pubmed nct search
Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial.
Diabetes care2018 May (month)PMID29483185doi:10.2337/dc17-1114via 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.