Study of JNJ-41443532 in Type 2 Diabetics

This is a randomized (study drug assigned by chance), double-blind, (neither doctor nor
participant knows the name of the assigned study drug), placebo-(looks like study drug but
has no active drug in it) and FDA approved and marketed drug controlled, 4-week study in
male and female participants with type 2 diabetes. The purpose of this study is to evaluate
the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is
distributed within the body and how it is removed from the body over time) and and
pharmacodynamics (the effects of the drug) over the study duration. Each participant will be
randomly assigned to one of four treatments: placebo, the FDA approved and marketed drug
called pioglitazone, or one of two doses of JNJ-41443532. For each participant, the study
will consist of a screening examination (within 45 days of first dose of study drug dosing
on Day 1), a 4-week double-blind treatment phase, and a final, follow-up examination
between 7-10 days after the last dose of study drug. Participants will stay in the study
center for three days at the beginning of the study and 3 days at the end of the study and
have blood samples taken to evaluate the pharmacokinetics and pharmacodynamics of the study
drug. Participants will return to the study center approximately every week during the
4-week treatment phase to collect blood samples and evaluate participant safety. Safety
assessments include monitoring of adverse events, evaluation of lab results, heart activity,
vital signs, and physical exams, including detailed eye exams. Participants will receive
study drug (JNJ-41443532, pioglitazone, or placebo) by mouth twice daily (i.e. one hour
before breakfast and 2 hours after dinner); planned doses for JNJ-41443532 are 250 and 1,000
mg.