CompletedPhase 3Results posted

Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

653

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-11%

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 IDNCT01296412

Org study ID0431-403

Timeline

Milestones

Study first posted2011-02-15estimated

Study start2011-03-11actual

Primary completion2012-02-29actual

Study completion2012-02-29actual

Results first posted2013-03-15estimated

Last update posted2017-06-09actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus.

•On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%.

•Capable of using a liraglutide pen device.

Exclusion criteria

•History of Type 1 Diabetes mellitus.

•Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening.

•Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder.

•Impaired liver function.

•Impaired kidney function.

•History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study.

•History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment.

•Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study.

•Participation in another study with an investigational drug or device within 12 weeks prior to screening.

•History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.

•Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks.

•Surgery within the prior 4 weeks or major surgery planned during the study.

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

•User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.

Endpoints (8)

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.

Glycemic / diabetes

8 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (A1C)

Time frame:Baseline and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · percent	95% CI
Sitagliptin +/- Glimepiride	-1.32	-1.42 - -1.23
Liraglutide	-1.42	-1.51 - -1.32

Difference in least squares mean0.0995% CI-0.05 - 0.23ANCOVA

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (A1C)

Time frame:Baseline and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline and Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Sitagliptin +/- Glimepiride	-33.7	-37.5 - -29.9
Liraglutide	-39.6	-43.6 - -35.7

Difference in least squares mean5.995% CI0.5 - 11.4ANCOVA

Secondary/registry result

Percentage of Participants Reaching A1C Goal of <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
Sitagliptin +/- Glimepiride	62.8	-
Liraglutide	72.3	-

Difference in percent-9.595% CI-17.4 - -1.5Miettinen & Nurminen

Secondary/registry result

Percentage of Participants Reaching A1C Goal of <6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
Sitagliptin +/- Glimepiride	33.8	-
Liraglutide	38.3	-

Difference in percent-4.595% CI-12.7 - 3.7Miettinen & Nurminen

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline and Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Reaching A1C Goal of <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching A1C Goal of <6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

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 over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial.
Diabetologia2013 Jul (month)PMID23604551doi:10.1007/s00125-013-2905-1via clinicaltrials gov reference derived + pubmed nct search

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.