DelfaGLP-1 Atlas

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CompletedPhase 2

Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

23

Recruiting sites

—

Enrollment

99

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT00085969
Org study ID2993-120

Timeline

Milestones

Study first posted2004-06-22estimated
Last update posted2015-02-23estimated
Study start2003-09 (month precision)
Primary completion2004-01actual (month precision)
Study completion2004-01actual (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

•Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

Exclusion criteria

•Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
•Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

Endpoints (5)

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
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from Baseline to Day 14 and to Day 28

Time frame:Baseline, Day 14, Day28

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28

Time frame:Baseline, Day 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28

Time frame:Baseline, Day 14, Day 28

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28

Time frame:Baseline, Day 14, Day 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in postprandial blood glucose concentrations from Baseline to Day 28

Time frame:Baseline, Week 28

Postprandial glucose

change from baseline, improvement

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.