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LIRA-LIXI™

CompletedPhase 4Results posted

Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Lixisenatide

Listed sites

Recruiting sites

—

Enrollment

404

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7.5-10.5%

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 IDNCT01973231

Org study IDNN2211-3867

Secondary ID2012-004984-27

Secondary IDU1111-1136-3644WHO

Timeline

Milestones

Study first posted2013-10-31estimated

Results first posted2015-12-22estimated

Last update posted2017-02-09estimated

Study start2013-10 (month precision)

Primary completion2014-11actual (month precision)

Study completion2014-11actual (month precision)

Assets

Investigational agents

Liraglutide Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening

•HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)

•Body Mass Index (BMI) equal to or above 20 kg/m^2

Exclusion criteria

•Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice)

•Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Screening calcitonin value equal to or above 50 ng/L

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

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

•Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula

•Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening

•Heart failure, New York Heart Association (NYHA) class IV

•Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

•Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Endpoints (14)

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 From Baseline

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide	-4.24	—
Lixisenatide	-3.69	—

Secondary/protocol endpoint

Change in Body Weight From Baseline

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c) From Baseline

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent (%) glycosylated haemoglobin	95% CI
Liraglutide	-1.809	—
Lixisenatide	-1.238	—

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) From Baseline

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) From Baseline

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
Liraglutide	-2.904	—
Lixisenatide	-1.644	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
LiraglutideYes	74.2	—
No	25.8	—
LixisenatideYes	45.5	—
No	54.5	—

Secondary/registry result

Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
LiraglutideYes	54.6	—
No	45.4	—
LixisenatideYes	26.2	—
No	73.8	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
LiraglutideYes	66.5	—
No	33.5	—
LixisenatideYes	41.9	—
No	58.1	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
LiraglutideEvents	540	—
Serious	13	—
Severe	10	—
Moderate	109	—
Mild	421	—
LixisenatideEvents	435	—
Serious	7	—
Severe	3	—
Moderate	84	—
Mild	348	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Weeks 0-26

Treatment-emergent AEs (any)

event count, event

Publications (4)

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

Long-term Cost-effectiveness of Two GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus in the Italian Setting: Liraglutide Versus Lixisenatide.
Clinical therapeutics2017 Jul (month)PMID28625506doi:10.1016/j.clinthera.2017.05.354via pubmed nct search
Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting.
Diabetes, obesity & metabolism2017 Jun (month)PMID28124820doi:10.1111/dom.12890via clinicaltrials gov reference derived + pubmed nct search
Liraglutide Versus Lixisenatide: Long-Term Cost-Effectiveness of GLP-1 Receptor Agonist Therapy for the Treatment of Type 2 Diabetes in Spain.
Diabetes therapy : research, treatment and education of diabetes and related disorders2017 Apr (month)PMID28224463doi:10.1007/s13300-017-0239-6via pubmed nct search
Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial.
Diabetes care2016 Sep (month)PMID27311491doi:10.2337/dc15-2479via 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.