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Delfa

← All trials/NCT02059564

UnknownPhase 1

A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus

Assets

Efpeglenatide / Exenatide / Liraglutide

Listed sites

1

Recruiting sites

1

Estimated enrollment

44

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18-45

Primary endpoint

•PK profile of acetaminophen

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 IDNCT02059564
Org study IDHM-EXC-102

Timeline

Milestones

Study first posted2014-02-11estimated
Last update posted2014-02-11estimated
Study start2013-12 (month precision)
Primary completion2014-10estimated (month precision)
Study completion2014-12estimated (month precision)

Assets

Investigational agents

EfpeglenatideExenatideLiraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
•History of type 2 diabetes
•Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
•Use of approved methods of contraception
•Ability to provide written informed consent

Exclusion criteria

•Type 1 diabetes
•Significant acute diabetic proliferative retinopathy or severe neuropathy
•Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
•Pregnant or lactating women
•Participation in an investigational study within 30 days prior to randomization
•History of any major surgery within 6 months prior to Screening
•History of any serious adverse reaction or hypersensitivity to any of the product components.
•History of renal disease or significantly abnormal kidney function tests at Screening
•History of hepatic disease or significantly abnormal liver function tests
•History of any active infection within 30 days prior to Randomization
•Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
•Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
•Donation or loss of >500 mL of blood or blood product within 56 days of Randomization

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
2
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Glucose metabolism

Time frame:13 weeks

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

PK profile of acetaminophen

Time frame:13 weeks

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Safety and tolerability

Time frame:18 weeks

Treatment-emergent AEs (any)

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

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.