Status:
COMPLETED
Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
Lead Sponsor:
Wellstat Therapeutics
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
21-72 years
Phase:
PHASE2
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 glycosy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00110851
Start Date
April 1 2005
End Date
August 1 2007
Last Update
August 23 2007
Active Locations (20)
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1
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States, 06708
2
University Clinical Research-DeLand
DeLand, Florida, United States, 32720
3
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
4
Genesis Research International
Longwood, Florida, United States, 32779