PF-06291874 Multiple Ascending Dose Study In Type 2 Diabetes Mellitus Patients
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.
Timeline
- Start
- 2013-05-13
- Primary completion
- 2014-01-10
- Completion
- 2014-03-01
Outcome
Mixed primary results
registry Placebo vs PF-06291874 5 mg; p = 0.7457; Least Square Mean Difference (Net) -2.77 (90% CI -16.93 to 11.38) NCT01856595 ↗
registry Placebo vs PF-06291874 15 mg; p = 0.0108; Least Square Mean Difference (Net) -21.64 (90% CI -35.47 to -7.81) NCT01856595 ↗
registry PF-06291874 15 mg vs Placebo; p = 0.2790; Least Square Mean Difference (Net) 10.47 (90% CI -5.50 to 26.43) NCT01856595 ↗
registry PF-06291874 30 mg vs Placebo; p = 0.0299; Least Square Mean Difference (Net) -19.33 (90% CI -33.89 to -4.76) NCT01856595 ↗
registry Placebo vs PF-06291874 100 mg; p = 0.0005; Least Square Mean Difference (Net) -29.43 (90% CI -42.28 to -16.57) NCT01856595 ↗
registry Placebo - Part B vs PF-06291874 30 mg - Part B; p = 0.1133; Least Square Mean Difference (Net) -11.89 (90% CI -24.26 to 0.48) NCT01856595 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PF-06291874 | Small molecule | 5 mg | Oral |
| Subject | PF-06291874 | Small molecule | 15 mg | Oral |
| Subject | PF-06291874 | Small molecule | 30 mg | Oral |
| Subject | PF-06291874 | Small molecule | 50 mg | Oral |
| Subject | PF-06291874 | Small molecule | 100 mg | Oral |
| Subject | PF-06291874 | Small molecule | 150 mg | Oral |