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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00575588 | 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period | PHASE3 | COMPLETED | 891 | — | — | Dec 1, 2007 | Aug 1, 2010 | Mar 21, 2012 | 94 | Finland, Germany +9 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
| Arm | Type | Description |
|---|---|---|
| Saxagliptin | EXPERIMENTAL | - |
| Glipizide | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Metformin | DRUG | open-label metformin |
| Sulphonylurea | DRUG | Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) |
| Saxagliptin | DRUG | Saxagliptin 5 mg tablets |
Inclusion Criteria: * Diagnosed with type 2 diabetes, * Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1, * HbA1c \>6.5% and ≤10.0% Exclusion Criteria: * Type 1 diabetes, * history of diabetic ketoacidosis or hyperosmolar non-ketoni...