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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00085969 | Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 99 | — | — | Sep 1, 2003 | Jan 1, 2004 | Feb 23, 2015 | 23 | United States |
Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)
| Arm | Type | Description |
|---|---|---|
| A1 - Placebo 0.04 mL twice daily | PLACEBO_COMPARATOR | - |
| A2 - Placebo 0.04 mL once daily | PLACEBO_COMPARATOR | - |
| A3 - Placebo 0.08 mL once daily | PLACEBO_COMPARATOR | - |
| B - Exenatide 10 mcg twice daily | EXPERIMENTAL | - |
| C - Exenatide 10 mcg once daily | EXPERIMENTAL | - |
| D - Exenatide 20 mcg once daily | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo 0.04 mL twice daily | DRUG | Subcutaneously injected, 0.04 mL, twice daily |
| Placebo 0.04 mL once daily | DRUG | Subcutaneously injected, 0.04 mL, once daily |
| Placebo 0.08 mL once daily | DRUG | Subcutaneously injected, 0.08 mL, once daily |
| B - Exenatide 10 mcg twice daily | DRUG | Subcutaneously injected, 10 mcg (0.04 mL), twice daily |
| C - Exenatide 10 mcg once daily | DRUG | Subcutaneously injected, 10 mcg (0.04 mL), once daily |
| Exenatide 20 mcg once daily | DRUG | Subcutaneously injected, 20 mcg (0.08 mL), once daily |
Inclusion Criteria: * Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. Exclusion Criteria: * Subject has a clinically significant history or presence of any of the following condit...