Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 206
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Detailed description:
This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: PF-06291874 intervention 2: Placebo
Intervention descriptions: intervention 1: study drug to be given as an oral tablet at 30, 60 or 100 mg intervention 2: oral tablet

Protocol document: