CompletedPhase 3Results posted

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

Efficacy and Safety 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

Recruiting sites

Actual enrollment

181

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00577824

Org study IDH8O-JE-GWBB

Timeline

Milestones

Study first posted2007-12-20estimated

Results first posted2009-12-31estimated

Last update posted2015-04-09estimated

Study start2008-01 (month precision)

Primary completion2008-11actual (month precision)

Study completion2008-11actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes.

•Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.

•Have HbA1c 7.0% to 10% at study start.

•Have a body weight >=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 glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.

•Have been treated with any exogenous insulin within 90 days before study start.

•Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.

•The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Endpoints (17)

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

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline, week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
5mcg Exenatide BID	-0.39	-
10mcg Exenatide BID	-1.54	-
Placebo BID	-0.47	-

p0.026ANCOVA

Secondary/protocol endpoint

Change in Waist Size

Time frame:baseline, week 24

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · cm	95% CI
5mcg Exenatide BID	-0.17	-
10mcg Exenatide BID	-1.81	-
Placebo BID	0.41	-

p0.003t-test, 2 sided

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:baseline, week 24

change from baseline, improvement

Posted result

Group	Mean · ratio (cm/cm)	95% CI
5mcg Exenatide BID	0.0016	-
10mcg Exenatide BID	-0.0108	-
Placebo BID	-0.0007	-

p0.208t-test, 2 sided

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

Time frame:baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of hemoglobin	95% CI
5mcg Exenatide BID	-1.34	-
10mcg Exenatide BID	-1.62	-
Placebo BID	-0.28	-

p<0.001ANCOVA

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c < 7.0%

Time frame:24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
5mcg Exenatide BID	67.1	-
10mcg Exenatide BID	71.0	-
Placebo BID	15.2	-

p<0.001Cochran-Armitage

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c < 6.5%

Time frame:24 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of participants	95% CI
5mcg Exenatide BID	36.6	-
10mcg Exenatide BID	47.2	-
Placebo BID	8.6	-

p<0.001Cochran-Armitage

Secondary/protocol endpoint

Change in Fasting Blood Glucose

Time frame:baseline, week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
5mcg Exenatide BID	-25.1	-
10mcg Exenatide BID	-29.0	-
Placebo BID	-7.6	-

p<0.002ANCOVA

Secondary/protocol endpoint

7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24

Time frame:baseline, week 24

descriptive

Posted result

Group	Mean · mg/dL	95% CI
5mcg Exenatide BID30 minutes prior to breakfast SMBG at week 0	169	-
30 minutes prior to breakfast SMBG at week 24	150	-
2hr post-breakfast SMBG at week 0	261	-
2hr post-breakfast SMBG at week 24	178	-
30 minutes prior to lunch SMBG at week 0	179	-
30 minutes prior to lunch SMBG at week 24	155	-
2hr post-lunch SMBG at week 0	263	-
2hr post-lunch SMBG at week 24	213	-
30 minutes prior to dinner SMBG at week 0	166	-
30 minutes prior to dinner SMBG at week 24	149	-
2hr post-dinner SMBG at week 0	246	-
2hr post-dinner SMBG at week 24	160	-
bedtime SMBG at week 0	216	-
bedtime SMBG at week 24	170	-
10mcg Exenatide BID30 minutes prior to breakfast SMBG at week 0	175	-
30 minutes prior to breakfast SMBG at week 24	140	-
2hr post-breakfast SMBG at week 0	263	-
2hr post-breakfast SMBG at week 24	149	-
30 minutes prior to lunch SMBG at week 0	189	-
30 minutes prior to lunch SMBG at week 24	152	-
2hr post-lunch SMBG at week 0	268	-
2hr post-lunch SMBG at week 24	195	-
30 minutes prior to dinner SMBG at week 0	176	-
30 minutes prior to dinner SMBG at week 24	140	-
2hr post-dinner SMBG at week 0	247	-
2hr post-dinner SMBG at week 24	141	-
bedtime SMBG at week 0	225	-
bedtime SMBG at week 24	151	-
Placebo BID30 minutes prior to breakfast SMBG at week 0	170	-
30 minutes prior to breakfast SMBG at week 24	167	-
2hr post-breakfast SMBG at week 0	254	-
2hr post-breakfast SMBG at week 24	257	-
30 minutes prior to lunch SMBG at week 0	179	-
30 minutes prior to lunch SMBG at week 24	182	-
2hr post-lunch SMBG at week 0	264	-
2hr post-lunch SMBG at week 24	254	-
30 minutes prior to dinner SMBG at week 0	173	-
30 minutes prior to dinner SMBG at week 24	181	-
2hr post-dinner SMBG at week 0	239	-
2hr post-dinner SMBG at week 24	247	-
bedtime SMBG at week 0	206	-
bedtime SMBG at week 24	212	-

Secondary/protocol endpoint

Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)

Time frame:baseline, week 24

change from baseline, improvement

Posted result

Group	Mean · ratio	95% CI
5mcg Exenatide BID	2.475	-
10mcg Exenatide BID	6.836	-
Placebo BID	-0.707	-

p0.708t-test, 2 sided

Secondary/protocol endpoint

Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)

Time frame:baseline, week 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Mean · ratio	95% CI
5mcg Exenatide BID	-0.541	-
10mcg Exenatide BID	-0.366	-
Placebo BID	-0.375	-

p0.974t-test, 2 sided

Secondary/protocol endpoint

Change in Serum Insulin

Time frame:baseline, week 24

change from baseline, improvement

Posted result

Group	Mean · mcU/mL	95% CI
5mcg Exenatide BID	-0.2	-
10mcg Exenatide BID	0.2	-
Placebo BID	-0.7	-

Secondary/protocol endpoint

Change in C-peptide

Time frame:baseline, week 24

C-peptide AUC

change from baseline, improvement

Posted result

Group	Mean · ng/mL	95% CI
5mcg Exenatide BID	0.05	-
10mcg Exenatide BID	0.07	-
Placebo BID	-0.08	-

p0.200t-test, 2 sided

Secondary/protocol endpoint

Change in 1,5-anhydroglucitol

Time frame:baseline, week 24

change from baseline, improvement

Posted result

Group	Mean · mcg/mL	95% CI
5mcg Exenatide BID	5.29	-
10mcg Exenatide BID	4.52	-
Placebo BID	0.66	-

p<0.001t-test, 2 sided

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:baseline, week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Mean · mg/dL	95% CI
5mcg Exenatide BID	-14.45	-
10mcg Exenatide BID	-7.01	-
Placebo BID	-4.80	-

p0.672t-test, 2 sided

Secondary/protocol endpoint

Change in Low Density Lipoprotein Cholesterol (LDL-C)

Time frame:baseline, week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Mean · mg/dL	95% CI
5mcg Exenatide BID	-8.89	-
10mcg Exenatide BID	-5.03	-
Placebo BID	-2.66	-

p0.580t-test, 2 sided

Secondary/protocol endpoint

Change in High Density Lipoprotein Cholesterol (HDL-C)

Time frame:baseline, week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Mean · mg/dL	95% CI
5mcg Exenatide BID	-4.63	-
10mcg Exenatide BID	-4.22	-
Placebo BID	-0.97	-

p0.014t-test, 2 sided

Secondary/protocol endpoint

Change in Triglycerides

Time frame:baseline, week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Mean · mg/dL	95% CI
5mcg Exenatide BID	4.00	-
10mcg Exenatide BID	4.13	-
Placebo BID	-4.60	-

p0.490t-test, 2 sided

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

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search
Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes.
Journal of diabetes investigation2011 Nov 30PMID24843529doi:10.1111/j.2040-1124.2011.00137.xvia CT.gov reference + pubmed nct search
Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks.
Journal of diabetes investigation2011 Jun 5PMID24843486doi:10.1111/j.2040-1124.2010.00084.xvia CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.