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Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
69
Recruiting sites
—
Enrollment
505
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 25-40•HbA1c 7-11%
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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
Weight & body composition
1 endpointChange in Body Weight
Time frame:baseline, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kg | 95% CI |
|---|---|---|
| Exenatide ArmBaseline body weight | 85.51 | — |
| Change in body weight at week 52 | -2.54 | — |
| Biphasic Insulin Aspart ArmBaseline body weight | 83.38 | — |
| Change in body weight at week 52 | 2.92 | — |
Glycemic / diabetes
4 endpointsChange in Glcosylated Hemoglobin (HbA1c)
Time frame:baseline, week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), percentage | 95% CI |
|---|---|---|
| Exenatide ArmBaseline HbA1c | 8.59 | — |
| Change in HbA1c at week 52 | -0.98 | — |
| Biphasic Insulin Aspart ArmBaseline HbA1c | 8.65 | — |
| Change in HbA1c at week 52 | -0.88 | — |
Percentage of Patients Achieving HbA1c <=7%
Time frame:52 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Exenatide Arm | 31.7 | — |
| Biphasic Insulin Aspart Arm | 24.1 | — |
Change in Fasting Serum Glucose
Time frame:baseline, week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (least_squares_mean), mmol/L | 95% CI |
|---|---|---|
| Exenatide ArmBaseline fasting serum glucose | 11.00 | — |
| Change in fasting serum glucose at week 52 | -1.75 | — |
| Biphasic Insulin Aspart ArmBaseline fasting serum glucose | 11.30 | — |
| Change in fasting serum glucose at week 52 | -1.64 | — |
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Time frame:baseline, week 52
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Exenatide ArmPre-breakfast: Baseline SMBG | 9.57 | — |
| Pre-breakfast: Change in SMBG at week 52 | -1.15 | — |
| After breakfast: Baseline SMBG | 12.30 | — |
| After breakfast: Change in SMBG at week 52 | -3.83 | — |
| Pre-lunch: Baseline SMBG | 9.38 | — |
| Pre-lunch: Change in SMBG at week 52 | -1.47 | — |
| After lunch: Baseline SMBG | 11.18 | — |
| After lunch: Change in SMBG at week 52 | -1.72 | — |
| Pre-dinner: Baseline SMBG | 9.35 | — |
| Pre-dinner: Change in SMBG at week 52 | -1.06 | — |
| After dinner: Baseline SMBG | 11.25 | — |
| After dinner: Change in SMBG at week 52 | -3.11 | — |
| 3:00 AM: Baseline SMBG | 9.08 | — |
| 3:00 AM: Change in SMBG at week 52 | -0.96 | — |
| Biphasic Insulin Aspart ArmPre-breakfast: Baseline SMBG | 9.86 | — |
| Pre-breakfast: Change in SMBG at week 52 | -1.68 | — |
| After breakfast: Baseline SMBG | 12.71 | — |
| After breakfast: Change in SMBG at week 52 | -3.06 | — |
| Pre-lunch: Baseline SMBG | 9.86 | — |
| Pre-lunch: Change in SMBG at week 52 | -2.40 | — |
| After lunch: Baseline SMBG | 11.39 | — |
| After lunch: Change in SMBG at week 52 | -1.76 | — |
| Pre-dinner: Baseline SMBG | 9.57 | — |
| Pre-dinner: Change in SMBG at week 52 | -1.52 | — |
| After dinner: Baseline SMBG | 11.68 | — |
| After dinner: Change in SMBG at week 52 | -2.44 | — |
| 3:00 AM: Baseline SMBG | 9.58 | — |
| 3:00 AM: Change in SMBG at week 52 | -1.95 | — |
Safety / tolerability / PK
2 endpointsPercentage of Patients With Hypoglycemic Events
Time frame:52 weeks
Documented hypoglycemia
threshold achievement, event
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Exenatide Arm | 53.0 | — |
| Biphasic Insulin Aspart Arm | 51.6 | — |
Change in Rate of Hypoglycemic Events
Time frame:baseline, week 52
Documented hypoglycemia
change from baseline, event
Posted result
| Group | Value (least_squares_mean), events per 30 days per patient | 95% CI |
|---|---|---|
| Exenatide ArmBaseline event rate | 0.22 | — |
| Change in event rate at week 52 | 0.19 | — |
| Biphasic Insulin Aspart ArmBaseline event rate | 0.18 | — |
| Change in event rate at week 52 | 0.26 | — |
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
- Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2012 Jun (month)PMID22236356doi:10.1111/j.1463-1326.2012.01561.xvia clinicaltrials gov reference derived + pubmed nct search
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.