DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT00382239

CompletedPhase 2

A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

14

Recruiting sites

—

Enrollment

153

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 IDNCT00382239
Org study IDH8O-JE-GWAV

Timeline

Milestones

Study first posted2006-09-28estimated
Last update posted2015-02-23estimated
Study start2006-09 (month precision)
Primary completion2007-05actual (month precision)
Study completion2007-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes.
•Have a body weight of >=50 kg.

Exclusion criteria

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
•Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
•Are treated with any exogenous insulin within 3 months of screening.
•Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
•Have characteristics contraindicating for concomitant medication, according to product-specific label.
•Have severe allergy or hypersensitivity to any drug.

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
3
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

componentsBody weight, absolute change (kg), Waist circumference, change

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects achieving HbA1c <7% at Week 12

Time frame:12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in fasting blood glucose from Visits 3 to 7

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in Serum lipids from Baseline to Week 12

Time frame:Baseline, Week 12

change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change

Publications (2)

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.