This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).

Condition	Treatment or Intervention	Phase
Type 2 Diabetes Mellitus	Drug: rosiglitazone  Drug: metformin  Drug: PN2034	Phase II

Further Study Details: 

Primary Outcomes: Safety; Effect on HbA1c levels
Secondary Outcomes: Effect on glucose control as measured by FPG; Effect on lipid levels
Expected Total Enrollment:  90

Ages Eligible for Study:  21 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• diagnosed with type 2 diabetes mellitus
• 21 to 65 years of age
• on stable doses of rosiglitazone and metformin (or Avandamet) for at least 3 months
• glycosylated hemoglobin (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
• 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 insulin, TZDs (excluding rosiglitazone) or any other oral or injected antidiabetic (excluding metformin or Avandamet) 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00110851

Connecticut
      Phoenix Internal Medicine Associates, Waterbury,  Connecticut,  06708,  United States; Recruiting
Florida
      CLIRECO, Inc., Tamarac,  Florida,  33321,  United States; Recruiting
      University Clinical Research-DeLand, Deland,  Florida,  32720,  United States; Recruiting
      Endocrine Clinical Research, Winter Park,  Florida,  32789,,  United States; Recruiting
      Genesis Research International, Longwood,  Florida,  32779,  United States; Recruiting
      Baptist Diabetes Associates, Miami,  Florida,  33156,  United States; Recruiting
Kansas
      PRN of Kansas, Wichita,  Kansas,  67203,  United States; Recruiting
North Carolina
      Piedmont Medical Research Associates, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Oregon
      Clinical Research Institute of Southern Oregon, PC, Medford,  Oregon,  97504,  United States; Recruiting
Pennsylvania
      Camp Hill Clinical Research Center, Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
      Clinical Trials Research Services, LLC, Pittsburgh,  Pennsylvania,  15206,  United States; Recruiting
Texas
      Diabetes & Glandular Disease Research Associates, P.A., San Antonio,  Texas,  78229,  United States; Recruiting
      Asha Kohli, M.D., Missouri City,  Texas,  77459,  United States; Recruiting
      Hansa B. Medley, M.D., Houston,  Texas,  77063,  United States; Recruiting
      Reichman & Associates, Sugar Land,  Texas,  77478,  United States; Recruiting

Study ID Numbers:  PN2034.05.001
Record last reviewed:  May 2005
Last Updated:  May 13, 2005
Record first received:  May 13, 2005
ClinicalTrials.gov Identifier:  NCT00110851
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17