Who is sponsoring NCT02206607?

NCT02206607 is sponsored by Pfizer.

What condition does NCT02206607 study?

NCT02206607 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT02206607?

Interventions: PF-04937319 IR MST, PF-04937319 MR 1, PF-04937319 MR 2, PF-04937319 MR 3.

What is the status of NCT02206607?

NCT02206607 is currently COMPLETED.

Last reviewed 2016-02-04 · How we verify

A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

NCT02206607 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	39
Start date	2014-09
Completion	2015-01

Conditions

Type 2 Diabetes Mellitus

Interventions

PF-04937319 IR MST
PF-04937319 MR 1
PF-04937319 MR 2
PF-04937319 MR 3

Primary outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] — 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 — 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.

Countries

United States