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

Wellstat Therapeutics20 sites in 1 country90 target enrollmentApril 2005

ConditionsType 2 Diabetes Mellitus

Drugsrosiglitazone metformin PN2034

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Wellstat Therapeutics
Enrollment: 90
Locations: 20
Primary Endpoint: Safety
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

August 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wellstat Therapeutics

Eligibility 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

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