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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02206607 | Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus. | PHASE1 | COMPLETED | 39 | — | — | Sep 1, 2014 | Jan 1, 2015 | Mar 4, 2016 | 2 | United States |
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
| Arm | Type | Description |
|---|---|---|
| PF-04937319 IR MST | EXPERIMENTAL | Reference formulation |
| PF-04937319 MR 1 | EXPERIMENTAL | Test MR #1 |
| PF-04937319 MR 2 | EXPERIMENTAL | Test MR #2 |
| PF-04937319 MR 3 | EXPERIMENTAL | Test MR #3 |
| Name | Type | Description |
|---|---|---|
| PF-04937319 IR MST | DRUG | Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch |
| PF-04937319 MR 1 | DRUG | Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST |
| PF-04937319 MR 2 | DRUG | Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST |
| PF-04937319 MR 3 | DRUG | Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST |
Inclusion Criteria: * Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs) Exclusion Criteria: * Patients with cardiovascular event within 6 months of screening * Patients...