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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00035984 | Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 734 | — | — | May 1, 2002 | Aug 1, 2003 | Feb 24, 2015 | 100 | United States |
| NCT00039026 | Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea | PHASE3 | COMPLETED | 377 | — | — | Feb 1, 2002 | Aug 1, 2003 | Feb 24, 2015 | 126 | United States |
| NCT00044694 | Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 156 | — | — | Aug 1, 2002 | May 1, 2003 | Feb 20, 2015 | 33 | United States |
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
| Arm | Type | Description |
|---|---|---|
| AC2993 5 mcg (0.02 mL) | EXPERIMENTAL | Placebo, then AC2993 5 mcg, then AC2993 5 mcg |
| AC2993 10mcg (0.04 mL) | EXPERIMENTAL | Placebo, then AC2993 5 mcg, then AC2993 10 mcg |
| Placebo 0.02 mL | PLACEBO_COMPARATOR | Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL |
| Placebo 0.04 mL | PLACEBO_COMPARATOR | Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL |
| Placebo 0.01 mL | PLACEBO_COMPARATOR | 2 week placebo lead-in followed by Placebo 0.01 mL |
| Placebo 0.03 mL | PLACEBO_COMPARATOR | 2 week placebo lead-in followed by Placebo 0.03 mL |
| AC2993 2.5 mcg | EXPERIMENTAL | 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL |
| AC2993 5.0 mcg | EXPERIMENTAL | 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL |
| AC2993 7.5 mcg | EXPERIMENTAL | 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL |
| AC2993 10.0 mcg | EXPERIMENTAL | 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL |
| Name | Type | Description |
|---|---|---|
| AC2993 | DRUG | Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily |
| Placebo | DRUG | Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily |
| Placebo 0.01 mL | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily |
| Placebo 0.02 mL | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily |
| Placebo 0.03 mL | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily |
| Placebo 0.04 mL | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily |
| AC2993 2.5 mcg | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily |
| AC2993 5.0 mcg | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily |
| AC2993 7.5 mcg | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily |
| AC2993 10.0 mcg | DRUG | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily |
Inclusion Criteria: * Subjects with Type 2 diabetes mellitus * Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening * BMI= 27-45 kg/m2 * HbA1c value between 7.5% and 11% Exclusion Criteria: * Treated with oral anti-diabetic medications other tha...