Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00110851
- Lead Sponsor
- Wellstat Therapeutics
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety Effect on HbA1c levels
- Secondary Outcome Measures
Name Time Method Effect on glucose control as measured by FPG Effect on lipid levels
Trial Locations
- Locations (20)
Endocrine Clinical Research
🇺🇸Winter Park, Florida, United States
Neem Research Group
🇺🇸Columbia, South Carolina, United States
Phoenix Internal Medicine Associates
🇺🇸Waterbury, Connecticut, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Center for Diabetes and Endocrine Care
🇺🇸Hollywood, Florida, United States
University Clinical Research-DeLand
🇺🇸DeLand, Florida, United States
Genesis Research International
🇺🇸Longwood, Florida, United States
PRN of Kansas
🇺🇸Wichita, Kansas, United States
CLIRECO, Inc.
🇺🇸Tamarac, Florida, United States
Andres Patron, DO PA
🇺🇸Pembroke Pines, Florida, United States
Medical Research Associates of Charlotte
🇺🇸Charlotte, North Carolina, United States
Unifour Medical Research Associates
🇺🇸Hickory, North Carolina, United States
Neem Research Group of Charlotte
🇺🇸Charlotte, North Carolina, United States
Neem Research Group of Raleigh
🇺🇸Raleigh, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Camp Hill Clinical Research Center
🇺🇸Camp Hill, Pennsylvania, United States
Oaks Medical Center
🇺🇸Spring, Texas, United States
Palmetto Medical Research Associates
🇺🇸Mt. Pleasant, South Carolina, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States