Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of type 2 diabetes mellitus and type 1 diabetes. It is being developed by AstraZeneca PLC (AZN) and has completed clinical trials evaluating its effect on glucose control in patients with type 2 diabetes treated with metformin or sulfonylurea, and on beta cell function in type 1 diabetes.
AC2993 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is in clinical development for metabolic conditions, specifically diabetes mellitus, and has completed multiple trials.
AC2993 is in Phase 2 clinical development. While some completed trials are listed as Phase 3, the overall development stage is Phase 2. It is an investigational drug and has not been approved by regulatory authorities.
AC2993 has completed four clinical trials: NCT00039013, NCT00044668, NCT00064714, and NCT01789957. These trials evaluated the drug's effect on glucose control in type 2 diabetes patients on metformin or sulfonylurea, its effect on beta cell function in type 1 diabetes, and an extension study.
AC2993 is also known as exenatide, a synthetic version of exendin-4. It is being studied for its glucose-lowering effects in type 2 diabetes. The drug is developed by AstraZeneca and has completed trials in patients with type 2 diabetes.