- Type 2 diabetes mellitus
- HbA1c > 7.5%.
- Recent (within the past 12 months) evidence or history of unstable concomitant
- Treatment with any oral hypoglycemic agent within 3 months before enrollment.
- The exception to these criteria is that subjects who are currently taking metformin
hydrochloride, in a stable dose (that is no changes in dose) for treatment of their
diabetes within the past 3 months or longer of enrollment may participate.