GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 4Results posted

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

368

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 IDNCT02008682

Org study IDNN2211-4075

Secondary IDU1111-1139-0016WHO

Timeline

Milestones

Study first posted2013-12-11estimated

Results first posted2015-12-22estimated

Last update posted2017-03-09actual

Study start2013-12 (month precision)

Primary completion2014-11actual (month precision)

Study completion2014-11actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age at least 18 years and below 80 years at the time of signing informed consent

•Subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening

•HbA1c 7.0-10.0% (both inclusive)

•Body mass index below or equal to 45.0 kg/m^2

Exclusion criteria

•Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days prior to screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness

•History of chronic pancreatitis or idiopathic acute pancreatitis

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

•Screening calcitonin value above or equal to 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)

•Any contraindications to liraglutide, sitagliptin or metformin according to local labelling

Endpoints (12)

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

Safety / tolerability / PK

Glycemic / diabetes

10 endpoints

Primary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

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	-1.666	—
Sitagliptin	-0.969	—

Primary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose

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	-2.347	—
Sitagliptin	-1.205	—

Secondary/registry result

Change From Baseline in 7-point Self-measured Plasma Glucose Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide	-2.25	—
Sitagliptin	-1.36	—

Secondary/registry result

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

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
Liraglutide	76.5	—
Sitagliptin	52.6	—

Secondary/registry result

Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

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
Liraglutide	61.7	—
Sitagliptin	26.3	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 7-point Self-measured Plasma Glucose Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:After 26 weeks of treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)

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 Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), episodes	95% CI
Liraglutide	2	—
Sitagliptin	1	—

Secondary/protocol endpoint

Number of Confirmed Hypoglycaemic Episodes

Time frame:Weeks 0-26

Documented hypoglycemia

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 liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial.
Diabetes, obesity & metabolism2016 Aug (month)PMID27060930doi:10.1111/dom.12674via 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.