Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
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
1 other identifier
interventional
90
1 country
20
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Apr 2005
Longer than P75 for phase_2 type-2-diabetes-mellitus
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 13, 2005
CompletedFirst Posted
Study publicly available on registry
May 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 23, 2007
August 1, 2007
May 13, 2005
August 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety
Effect on HbA1c levels
Secondary Outcomes (2)
Effect on glucose control as measured by FPG
Effect on lipid levels
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed with type 2 diabetes mellitus
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Phoenix Internal Medicine Associates
Waterbury, Connecticut, 06708, United States
University Clinical Research-DeLand
DeLand, Florida, 32720, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
Genesis Research International
Longwood, Florida, 32779, United States
Baptist Diabetes Associates
Miami, Florida, 33156, United States
Andres Patron, DO PA
Pembroke Pines, Florida, 33028, United States
CLIRECO, Inc.
Tamarac, Florida, 33321, United States
Endocrine Clinical Research
Winter Park, Florida, 32789,, United States
PRN of Kansas
Wichita, Kansas, 67203, United States
Medical Research Associates of Charlotte
Charlotte, North Carolina, 28211, United States
Neem Research Group of Charlotte
Charlotte, North Carolina, 28262, United States
Unifour Medical Research Associates
Hickory, North Carolina, 28601, United States
Neem Research Group of Raleigh
Raleigh, North Carolina, 27609, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, 17011, United States
Neem Research Group
Columbia, South Carolina, 29201, United States
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, 29464, United States
Oaks Medical Center
Spring, Texas, 77386, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2005
First Posted
May 16, 2005
Study Start
April 1, 2005
Study Completion
August 1, 2007
Last Updated
August 23, 2007
Record last verified: 2007-08