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

Sponsored by:	Wellstat Therapeutics
Information provided by:	Wellstat Therapeutics
ClinicalTrials.gov Identifier:	NCT00110851

Purpose

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).

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: rosiglitazone Drug: metformin Drug: PN2034	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Avandamet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wellstat Therapeutics:

Primary Outcome Measures:

Safety
Effect on HbA1c levels

Secondary Outcome Measures:

Effect on glucose control as measured by FPG
Effect on lipid levels

Estimated Enrollment:	90
Study Start Date:	April 2005
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	21 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110851

Locations

United States, Connecticut
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States, 06708
United States, Florida
CLIRECO, Inc.
Tamarac, Florida, United States, 33321
University Clinical Research-DeLand
DeLand, Florida, United States, 32720
Endocrine Clinical Research
Winter Park, Florida, United States, 32789,
Genesis Research International
Longwood, Florida, United States, 32779
Baptist Diabetes Associates
Miami, Florida, United States, 33156
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Andres Patron, DO PA
Pembroke Pines, Florida, United States, 33028
United States, Kansas
PRN of Kansas
Wichita, Kansas, United States, 67203
United States, North Carolina
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
Medical Research Associates of Charlotte
Charlotte, North Carolina, United States, 28211
Unifour Medical Research Associates
Hickory, North Carolina, United States, 28601
Neem Research Group of Raleigh
Raleigh, North Carolina, United States, 27609
Neem Research Group of Charlotte
Charlotte, North Carolina, United States, 28262
United States, Oklahoma
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, United States, 17011
United States, South Carolina
Neem Research Group
Columbia, South Carolina, United States, 29201
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Oaks Medical Center
Spring, Texas, United States, 77386

Sponsors and Collaborators

Wellstat Therapeutics

More Information

Study ID Numbers:	PN2034.05.001
Study First Received:	May 13, 2005
Last Updated:	August 21, 2007
ClinicalTrials.gov Identifier:	NCT00110851
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wellstat Therapeutics:

diabetes, type 2

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009