Phase 1
N=42
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.
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02206607 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] — 10690; 3187; 2725; 3430 nanogram*hour/milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-04937319 IR MST (Drug); PF-04937319 MR 1 (Drug); PF-04937319 MR 2 (Drug); PF-04937319 MR 3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] |
10690; 3187; 2725; 3430 | — |
| PRIMARY Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 |
159.47; 176.24; 170.85; 180.47; NA; 15.55 | 1.0000 |
| SECONDARY Maximum Observed PF-04937319 Plasma Concentration (Cmax) |
641.2; 161.8; 171.3; 236.2 | — |
| SECONDARY PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) |
413.2; 124.3; 154.3; 202.1 | — |
| SECONDARY PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) |
324.7; 74.49; 58.88; 77.92 | — |
| SECONDARY PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) |
171.1; 56.04; 39.38; 48.17 | — |
| SECONDARY Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) |
3.748; 2.887; 4.350; 4.903 | — |
| SECONDARY Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) |
8.00; 6.00; 5.00; 5.00 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) |
10560; 3287; 2644; 3369 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) |
8.648; 12.10; 13.52; 12.62 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
2; 16; 11; 16; 10; 0 | — |
Summary
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
Eligibility Criteria
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 with diabetic complications
- Female subjects who are pregnant or planning to become pregnant
- Subjects with unstable medical conditions (eg, hypertension)
Data sourced from ClinicalTrials.gov (NCT02206607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.