CompletedPhase 2

Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes

Lead sponsor

Hanmi Pharmaceutical Company Limited

Assets

Efpeglenatide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

Actual enrollment

254

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-10%

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 IDNCT02057172

Org study IDHM-EXC-203

Timeline

Milestones

Study first posted2014-02-06estimated

Last update posted2016-08-09estimated

Study start2014-01 (month precision)

Primary completion2014-10actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

Efpeglenatide Exenatide GLP-1 / incretin class catch-all Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Ages eligible for study : 18 years to 74 years

•Genders eligible for study : Male and Female

•Diagnosed with T2DM

•Received diet and exercise therapy with or without metformin monotherapy

•HbA1c levels of between ≥ 7.0% and ≤ 10.0%

•Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control

•Written informed consent must be obtained

Exclusion criteria

•Pregnant or nursing (lactating) women

•Diagnosis of type 1 diabetes mellitus

•Uncontrolled diabetes defined as a FPG level of > 240 mg/dL

•A significant change in body weight in the 3 months before screening

•Any history of GI intolerance

•Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC

•Known history of chronic pancreatitis

•A history of alcohol or drug abuse or drug addiction

Endpoints (9)

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

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body weight

Time frame:Up to day 127

descriptive, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks

Time frame:Up to 127 days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma glucose levels (FPG)

Time frame:Up to 127 days

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

7-point glucose profile

Time frame:Up to day 127

descriptive

Secondary/protocol endpoint/low confidence

Other glycaemic control parameters

Time frame:Up to day 127

descriptive

Secondary/protocol endpoint

Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%

Time frame:Up to 127 days

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Serum lipid profile

Time frame:Up to day 127

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Assess the safety and tolerability of HM11260C

Time frame:Up to day 127

descriptive

Other/protocol endpoint

Assess the immunogenicity of HM11260C

Time frame:Up to day 127

Immunogenicity (ADA)

descriptive

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

Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.
Diabetes care2019 Sep (month)PMID31320446doi:10.2337/dc18-2648via 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 tableno registry results posted yet

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.