CompletedPhase 2

Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Lead sponsor

Hanmi Pharmaceutical Company Limited

Assets

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

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-10%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01452451

Org study IDHM-EXC-202

Timeline

Milestones

Study first posted2011-10-14estimated

Last update posted2016-08-09estimated

Study start2011-12 (month precision)

Primary completion2013-06actual (month precision)

Assets

Investigational agents

Efpeglenatide Exenatide GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Is male or female and 18 to 65 years of age, inclusive, at screening

•Has a history of T2DM and a stable dose of metformin

•Has HbA1c levels at screening between 7% and 10%

Exclusion criteria

•Is pregnant or lactating

•Has type 1 diabetes

•Has a significant change in body weight in the 3 months before screening

•Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening

•Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g.

•Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome

•Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.

•Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding

•Has any acute illness within 5 days before first study drug administration

•Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis

•Is a heavy tobacco user(more than 10 cigarettes a day)

•Is a heavy alcohol user

•Has a positive screen for drugs of abuse

Endpoints (3)

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

Safety / tolerability / PK

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

The pharmacodynamics in repeat-dose

Time frame:Up to 106 days

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of subjects with adverse events as a measure of safety and tolerability

Time frame:Up to 106 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The pharmacokinetics in repeat-dose

Time frame:Day 1 up to Day 92

Plasma concentration (steady state)

concentration, descriptive

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.