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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01338870 | Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes | PHASE2 | COMPLETED | 301 | — | — | Jun 1, 2011 | Mar 1, 2012 | Apr 23, 2013 | 42 | United States, Canada +4 |
| NCT01469065 | A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes | PHASE1 | COMPLETED | 82 | — | — | Dec 1, 2011 | May 1, 2012 | Oct 30, 2013 | 3 | United States, Japan |
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for PF-04991532 and sitagliptin |
| 25 mg PF-04991532 | EXPERIMENTAL | - |
| 75 mg PF-04991532 | EXPERIMENTAL | - |
| 150 mg PF-04991532 | EXPERIMENTAL | - |
| 300 mg PF-04991532 | EXPERIMENTAL | - |
| Sitagliptin 100 mg | ACTIVE_COMPARATOR | - |
| PF-04991532 | EXPERIMENTAL | PF-04991532 experimental study medication |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablets (n=4), 0 mg twice daily for 84 days |
| 25 mg PF-04991532 | DRUG | Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
| 75 mg PF-04991532 | DRUG | Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days |
| 150 mg PF-04991532 | DRUG | Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
| 300 mg PF-04991532 | DRUG | Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days |
| Sitagliptin 100 mg | DRUG | Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days. |
| PF-04991532 | DRUG | Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days |
| PF-0499132 | DRUG | Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days |
Inclusion Criteria: Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2 Exclusion Criteria: Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pr...