DelfaGLP-1 Atlas

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CompletedPhase 2

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

A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin

Assets

Efpeglenatide / Exenatide

Listed sites

1

Recruiting sites

—

Enrollment

209

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 IDNCT02081118
Org study IDHM-EXC-204

Timeline

Milestones

Study first posted2014-03-07estimated
Last update posted2016-08-09estimated
Study start2014-02 (month precision)
Primary completion2015-03actual (month precision)
Study completion2015-04actual (month precision)

Assets

Investigational agents

EfpeglenatideExenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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
•Taking a stable dose of 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 at screening
•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 acute or chronic pancreatitis
•A history of alcohol or drug abuse or drug addiction

Endpoints (11)

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
7
Safety / tolerability / PK
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:Up to day 155

descriptive, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks

Time frame:Up to day 155

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma glucose levels (FPG)

Time frame:Up to day 155

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

7-point glucose profile

Time frame:Up to day 155

descriptive

Secondary/protocol endpoint

Fasting insulin

Time frame:Up to day 155

change from baseline, improvement

Secondary/protocol endpoint/low confidence

C-peptide

Time frame:Up to day 155

change from baseline, improvement

Secondary/protocol endpoint

Glucagon

Time frame:Up to day 155

change from baseline, improvement

Secondary/protocol endpoint

Glycated albumin

Time frame:Up to day 155

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Serum lipid profile

Time frame:Up to day 155

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Number of Participants with Adverse Events by HM11260C

Time frame:Up to day 155

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Number of Participants with Immunogenicity by HM11260C

Time frame:Up to day 155

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.