DelfaGLP-1 Atlas

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CompletedPhase 2

Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

7

Recruiting sites

—

Enrollment

45

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-11%

Primary endpoint

•Assess the safety, tolerability

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 IDNCT00103935
Org study ID2993LAR-104

Timeline

Milestones

Study first posted2005-02-18estimated
Last update posted2015-02-24estimated
Study start2005-02 (month precision)
Primary completion2005-10actual (month precision)
Study completion2005-10actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
•Has HbA1c of 7.1% to 11.0%, inclusive.
•Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.

Exclusion criteria

•Received any investigational drug within 3 months prior to screening.
•Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
•Participated previously in an exenatide clinical study.

Endpoints (6)

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
3
Weight & body composition
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

Time frame:Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).

Time frame:Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

Time frame:Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15

Time frame:Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)

Time frame:Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus

Time frame:Various time intervals from Day 1 to Week 15

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.