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

May 13, 2005
August 21, 2007
April 2005
Not Provided
  • Safety
  • Effect on HbA1c levels
Same as current
Complete list of historical versions of study NCT00110851 on ClinicalTrials.gov Archive Site
  • Effect on glucose control as measured by FPG
  • Effect on lipid levels
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: rosiglitazone
  • Drug: metformin
  • Drug: PN2034
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
August 2007
Not Provided

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
Both
21 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00110851
PN2034.05.001
Not Provided
Not Provided
Wellstat Therapeutics
Not Provided
Not Provided
Wellstat Therapeutics
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP