Primary Outcome Measures:
- Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
- Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
- Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
- Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters
The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.