Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
exenatide twice daily · 1 trial · 1 indication
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...
Exenatide twice daily is a small molecule drug being developed by AstraZeneca PLC for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 development, with one completed Phase 3 trial.
Exenatide twice daily is intended for the treatment of Type 2 Diabetes Mellitus. It is being studied in patients with this condition, as part of a Phase 3 clinical trial.
Exenatide twice daily is in Phase 3 development. There is one completed Phase 3 trial, and no active trials are currently listed. The completed trial enrolled 494 participants.
The Phase 3 trial, NCT00434954, compared exenatide plus metformin to insulin aspart plus metformin on glycemic control and hypoglycemia in patients with Type 2 Diabetes. It was a randomized, active-controlled study conducted in Germany, enrolling 494 adults aged 18 and older.
The Phase 3 trial for exenatide twice daily was randomized but not double-blind. It used an active control, meaning patients received either exenatide plus metformin or insulin aspart plus metformin. The trial was completed.
Eligible participants were adults aged 18 years and older with Type 2 Diabetes Mellitus. The trial was open to all sexes and did not include healthy volunteers. It was conducted in Germany.