DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00035984

CompletedPhase 3

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

100

Recruiting sites

—

Enrollment

734

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-45•HbA1c 7.5-11%

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 IDNCT00035984
Org study ID2993-115

Timeline

Milestones

Study first posted2002-05-08estimated
Last update posted2015-02-24estimated
Study start2002-05 (month precision)
Primary completion2003-08actual (month precision)
Study completion2003-08actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age16 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects with Type 2 diabetes mellitus
•Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
•BMI= 27-45 kg/m2
•HbA1c value between 7.5% and 11%

Exclusion criteria

•Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
•Patients treated previously with AC2993
•Patients presently treated with insulin

Endpoints (7)

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
6
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from Baseline to each intermediate visit and Week 30

Time frame:Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Change in HbA1c from Baseline to Week 30

Time frame:Baseline (Day 1) to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c from baseline (Day 1) to each of the intermediate visits

Time frame:Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30

Time frame:Baseline (Day 1) and Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30

Time frame:Baseline (Day 1), and Week 30

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

The time to achieve specific HbA1c target values of < 7% and < 8%

Time frame:Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

HbA1c <7.0% achievement

time to event, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more

Time frame:Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

time to event, improvement

componentsHbA1c, change, HbA1c, change

Publications (3)

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.