Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet) Therapy

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: rosiglitazone
* Drug: metformin
* Drug: PN2034


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with type 2 diabetes mellitus 21 to 72 years of age taking rosiglitazone and metformin (or Avandamet) for at least 3 months, and on a stable dose of rosiglitazone (or Avandamet) for at least 2 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosiglitazone|nan|
|Drug: metformin|nan|
|Drug: PN2034|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Effect on HbA1c levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on glucose control as measured by FPG |  |  | 
| Effect on lipid levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, type 2