safety and tolerability study of mbx-2044 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to collect 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.

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.

Eligibility criteria:
inclusion criteria: * type 2 diabetes previously controlled with up to one or two non-tzd hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., prandin®, starlix®), metformin (e.g., glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or byetta® * all female patients must be either surgically sterile or post-menopausal. * male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception. * bmi 24-44 kg/m2. * patients must have a fpg ≤ 200 mg/dl at screening. * patients must have hemoglobin a1c ≥ 6.5%, ≤ 10.0% at screening. * electrocardiogram (ecg) and chest x-ray must be normal, or considered not clinically significant, for participation in this study. * patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication. exclusion criteria: * history of type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy. * history of tzd use (actos or avandia) within 6 months of screening visit. * history of tzd discontinuation due to lack of efficacy. * history of congestive heart failure within last 5 years. * history of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year. * malignancy within the last 5 years (except resected basal cell carcinoma). * ongoing active infection. * change in treatment with lipid-lowering agent within 7 days of screening visit. * current or expected requirement for anticoagulant therapy \[except for low-dose aspirin ≤ 325 mg/d or plavix® ≤ 75 mg/d\]. * current or expected treatment with phenytoin for the duration of the study. * known hypersensitivity to nsaids.

Keywords: type 2 diabetes mellitus