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

This study has been completed.
Sponsor:
Information provided by:
Wellstat Therapeutics
ClinicalTrials.gov Identifier:
NCT00110851
First received: May 13, 2005
Last updated: August 21, 2007
Last verified: August 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Clinical Research-DeLand
DeLand, Florida, United States, 32720
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Genesis Research International
Longwood, Florida, United States, 32779
Baptist Diabetes Associates
Miami, Florida, United States, 33156
Andres Patron, DO PA
Pembroke Pines, Florida, United States, 33028
CLIRECO, Inc.
Tamarac, Florida, United States, 33321
Endocrine Clinical Research
Winter Park, Florida, United States, 32789,
United States, Kansas
PRN of Kansas
Wichita, Kansas, United States, 67203
United States, North Carolina
Medical Research Associates of Charlotte
Charlotte, North Carolina, United States, 28211
Neem Research Group of Charlotte
Charlotte, North Carolina, United States, 28262
Unifour Medical Research Associates
Hickory, North Carolina, United States, 28601
Neem Research Group of Raleigh
Raleigh, North Carolina, United States, 27609
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
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

No publications provided

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

Keywords provided by Wellstat Therapeutics:
diabetes, type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014