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

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ClinicalTrials.gov Identifier: NCT00110851
Recruitment Status : Completed
First Posted : May 16, 2005
Last Update Posted : August 23, 2007
Sponsor:
Information provided by:
Wellstat Therapeutics

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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: rosiglitazone Drug: metformin Drug: PN2034 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Safety
  2. Effect on HbA1c levels

Secondary Outcome Measures :
  1. Effect on glucose control as measured by FPG
  2. Effect on lipid levels


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110851


Locations
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Sponsors and Collaborators
Wellstat Therapeutics
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ClinicalTrials.gov Identifier: NCT00110851    
Other Study ID Numbers: PN2034.05.001
First Posted: May 16, 2005    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: August 2007
Keywords provided by Wellstat Therapeutics:
diabetes, type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs