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Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
29
Recruiting sites
—
Enrollment
239
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7-10%
Primary endpoint
•24-hour Mean Weighted Glucose
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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.
Glycemic / diabetes
6 endpointsChange in 24-hour Mean Weighted Glucose
Time frame:Day 27/28
change from baseline, improvement
Posted result
| Group | Value (mean), (mg/dL) | 95% CI |
|---|---|---|
| EQW + MetBaseline (Day -1/1) | 185.7 | — |
| Day 27/28 | 158.3 | — |
| Change from Baseline to Day 27/28 | -26.0 | — |
| Change from Baseline to Day 69/70 | -30.8 | — |
| Placebo + MetBaseline (Day -1/1) | 183.8 | — |
| Day 27/28 | 176.9 | — |
| Change from Baseline to Day 27/28 | -5.3 | — |
| Change from Baseline to Day 69/70 | -3.0 | — |
Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
Time frame:Day 64/65
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| EQW + Met | 5.2 | — |
| Placebo + Met | -6.9 | — |
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Time frame:Day 22/Day70
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| EQW + MetBaseline to Day 22 | -29.6 | — |
| Baseline to Day 70 | -41.9 | — |
| Placebo + MetBaseline to Day 22 | -1.9 | — |
| Baseline to Day 70 | -5.0 | — |
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Time frame:Day 22 and Day 64
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mg/dL | 95% CI |
|---|---|---|
| EQW + MetBaseline to Day 22 | -32.1 | — |
| Baseline to Day 64 | -44.4 | — |
| Placebo + MetBaseline to Day 22 | -2.0 | — |
| Baseline to Day 64 | -6.0 | — |
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Time frame:Week 4 and Week 10
change from baseline, improvement
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Time frame:Day 22 and Day 70
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), % Alc | 95% CI |
|---|---|---|
| EQW + MetChange from baseline to Day 22 | -0.30 | — |
| Change from baseline to Day 70 | -0.92 | — |
| Placebo + MetChange from baseline to Day 22 | -0.10 | — |
| Change from baseline to Day 70 | -0.20 | — |
Provenance
Sources
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.