Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

Inclusion criteria

• diagnosed with type 2 diabetes mellitus
• 21 to 65 years of age
• on stable doses of insulin (>/= 40 units/day) alone or with metformin for at least 3 months
• HbA1c level of >/=7.5% but </=10.0%
• fasting blood sugar level >/= 125 mg/dL but </= 279 mg/dL
• BMI 26-43 kg/m2
• direct bilirubin < 1.5x the upper limit of normal (ULN)
• serum creatinine < 1.5 mg/dL (males) or < 1.4 mg/dL (females)
• blood urea nitrogen (BUN)</=40 mg/dL
• all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant
• ECG normal, or abnormalities not clinically significant
• surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at Screening
• able to perform daily self-monitoring of blood glucose (SMBG) tests
• willing and able to sign an informed consent form

Exclusion criteria

• diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis
• treatment with TZDs or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment
• change in lipid-lowering medication within 2 months of screening
• taken systemic corticosteroids within 1 month prior to screening or during study treatment
• history of or current/active cardiovascular disease
• significant current pulmonary conditions
• significant thyroid disease
• CPK value > 3x ULN
• a female who is pregnant or lactating
• systolic BP > 160 mm Hg or a diastolic BP > 90 mm Hg at screening
• previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization
• liver function tests (ALT, AST, ALP) > 2 times ULN, or active liver disease at screening
• history of positive HIV
• positive hepatitis B test at screening
• weight loss or gain >/= 15 lbs within 3 months of screening
• history of substance abuse (including alcohol abuse) within 2 years prior to screening
• donated and/or received any blood or blood products within 3 months prior to randomization
• taken an investigational study medication within 30 days prior to screening or during the study