Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00434954 | Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes | PHASE3 | COMPLETED | 494 | — | — | Feb 1, 2007 | Jun 1, 2009 | Apr 7, 2015 | 39 | Germany |
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26
| Arm | Type | Description |
|---|---|---|
| Exenatide Twice Daily (BID) | EXPERIMENTAL | - |
| Premixed Insulin Aspart Twice Daily (BID) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| exenatide twice daily (BID) | DRUG | subcutaneous injection (5 mcg or 10 mcg), twice a day |
| premixed insulin aspart twice daily (BID) | DRUG | subcutaneous injection (titrated appropriately), twice a day |
Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazo...