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LIRA-SWITCH™

CompletedPhase 4Results posted

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

106

Recruiting sites

—

Enrollment

407

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7.5-9.5%

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 IDNCT01907854

Org study IDNN2211-4059

Secondary ID2012-004931-22

Secondary IDCTRI/2014/05/004623Clinical Trial Registry India (CTRI)

Secondary IDU1111-1136-2073WHO

Timeline

Milestones

Study first posted2013-07-25estimated

Study start2013-12-02actual

Primary completion2015-06-15actual

Study completion2015-06-15actual

Results first posted2016-07-01estimated

Last update posted2018-10-02actual

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

•- 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 type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose

•- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)

•- Body mass index equal to or above 20 kg/m^2

Exclusion criteria

•- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol

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

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

•- 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 or multiple endocrine neoplasia syndrome type 2

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

•- Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit

•- Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m^2 per modification of diet in renal disease formula

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

•- Heart failure, New York Heart Association class IV

•- Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:From baseline to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide	-3.32	—
Sitagliptin	-1.80	—

Treatment difference-1.6795% CI-2.34 – -0.99p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Change in Body Weight

Time frame:From baseline to 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:From baseline to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycosylated haemoglobin	95% CI
Liraglutide	-1.146	—
Sitagliptin	-0.529	—

Treatment difference-0.6195% CI-0.82 – -0.40p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:From baseline to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose

Time frame:From baseline to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), nmol/L	95% CI
Liraglutide	-1.967	—
Sitagliptin	-0.588	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%)	95% CI
LiraglutideYes	50.6	—
No	49.4	—
SitagliptinYes	26.9	—
No	73.1	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:From baseline to 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 Target) (y/n)

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

4 endpoints

Secondary/registry result

Change in Fasting Blood Lipids

Time frame:From baseline to week 26

ratio, improvement

componentsTotal cholesterol, change, LDL-C, change, VLDL, change, HDL-C, change, Triglycerides, change, Free fatty acids, change

Posted result

Group	Value (mean), ratio	95% CI
LiraglutideTotal cholesterol	1.011	—
LDL cholesterol	1.049	—
VLDL cholesterol	1.062	—
HDL cholesterol	1.004	—
Triglycerides	1.089	—
Free Fatty acids	1.086	—
SitagliptinTotal cholesterol	1.045	—
LDL cholesterol	1.121	—
VLDL cholesterol	1.075	—
HDL cholesterol	0.997	—
Triglycerides	1.099	—
Free Fatty acids	1.104	—

Secondary/registry result

Change in Systolic Blood Pressure and Diastolic Blood Pressure

Time frame:From baseline to week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
LiraglutideSystolic Blood Pressure	-3.6	—
Diastolic Blood Pressure	-0.23	—
SitagliptinSystolic Blood Pressure	-2.57	—
Diastolic Blood Pressure	-0.81	—

Secondary/protocol endpoint

Change in Fasting Blood Lipids

Time frame:From baseline to week 26

ratio, improvement

Secondary/protocol endpoint

Change in Systolic Blood Pressure and Diastolic Blood Pressure

Time frame:From baseline to week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:During 26 weeks of treatment plus one week follow-up period.

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), number of events	95% CI
Liraglutide	455	—
Sitagliptin	318	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:During 26 weeks of treatment plus one week follow-up period.

Treatment-emergent AEs (any)

event count, event

Publications (1)

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

Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial.
Diabetes, obesity & metabolism2016 Dec (month)PMID27381275doi:10.1111/dom.12736via CT.gov reference

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.