Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
NCT ID: NCT00110851
Last Updated: 2007-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2005-04-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rosiglitazone
metformin
PN2034
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
72 Years
ALL
No
Sponsors
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Wellstat Therapeutics
INDUSTRY
Locations
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Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States
University Clinical Research-DeLand
DeLand, Florida, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
Genesis Research International
Longwood, Florida, United States
Baptist Diabetes Associates
Miami, Florida, United States
Andres Patron, DO PA
Pembroke Pines, Florida, United States
CLIRECO, Inc.
Tamarac, Florida, United States
Endocrine Clinical Research
Winter Park, Florida, United States
PRN of Kansas
Wichita, Kansas, United States
Medical Research Associates of Charlotte
Charlotte, North Carolina, United States
Neem Research Group of Charlotte
Charlotte, North Carolina, United States
Unifour Medical Research Associates
Hickory, North Carolina, United States
Neem Research Group of Raleigh
Raleigh, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, United States
Neem Research Group
Columbia, South Carolina, United States
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, United States
Oaks Medical Center
Spring, Texas, United States
Countries
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Other Identifiers
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PN2034.05.001
Identifier Type: -
Identifier Source: org_study_id