Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AC2993 (exenatide)
AC2993 · 7 trials · 4 indications
Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).
Assess whether patients treated with AC2993 (with or without concomitant immunosuppression) will display at least a 50% improvement in their basal C-peptide level. C-peptide level is a surrogate measure for insulin production.
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
| Arm | Type | Description |
|---|---|---|
| Open-label AC2993 | EXPERIMENTAL | - |
| AC2993 | EXPERIMENTAL | 5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period |
| 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 |
| Group 1 | EXPERIMENTAL | Group 1 will receive immunosuppression and AC2993; then immunosuppression only |
| Group 2 | EXPERIMENTAL | Group 2 will receive AC2993 only; then neither immunosuppression nor AC2993 |
| Group 3 | EXPERIMENTAL | Group 3 will receive immunosuppression and AC2993; then immunosuppression and AC2993 |
| Group 4 | EXPERIMENTAL | Group 4 will receive AC2993 only; then AC2993 only |
| 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 | 4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg 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 |
| AC2993 (exenatide) | DRUG | Dose-escalation beginning with 2.5 μg administered subcutaneously twice per day (BID); then to 2.5 μg four times a day (QID); then to 5 μg four times a day; then to 10 μg four times a day. |
| daclizumab (immunosuppressive) | DRUG | 2 mg/kg intravenously infused over 30 minutes every month for 12 months |
| 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 |
All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception: * Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study terminati...
AC2993 is an investigational small molecule developed by AstraZeneca PLC for metabolic conditions, specifically diabetes. It has been studied in Type 2 Diabetes Mellitus and Diabetes Mellitus, including a Phase 2 trial in Type 1 Diabetes. AC2993 is also known as exenatide and has been evaluated across multiple completed clinical trials.
AC2993 has been studied for Type 2 Diabetes Mellitus, with trials evaluating its effect on glucose control and safety. Studies also examined its use in patients treated with metformin, sulfonylurea, or a combination of both. The program includes completed Phase 2 and Phase 3 trials in this indication.
AC2993 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of AC2993 in diabetes, including studies in Type 2 Diabetes Mellitus and Type 1 Diabetes.
AC2993 is in Phase 2 development. Its clinical program includes completed Phase 2 and Phase 3 trials, with no active trials currently listed. The studies enrolled a total of 1,267 participants across diabetes indications.
AC2993 has been evaluated in completed trials including NCT01789957, an extension study in Type 2 Diabetes Mellitus; NCT00064714, a Phase 2 study in Type 1 Diabetes; NCT00044694, a Phase 2 glucose control study; and NCT00044668, a Phase 3 study in patients on metformin or sulfonylurea.
Yes, AC2993 is also known as exenatide. The alternative names AC2993 2.5 mcg and AC2993 (exenatide) refer to the same investigational compound developed by AstraZeneca PLC for diabetes indications.