A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

Wellstat Therapeutics18 sites in 1 country90 target enrollmentMay 2005

ConditionsType 2 Diabetes Mellitus

DrugsPN2034 Insulin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Wellstat Therapeutics
Enrollment: 90
Locations: 18
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 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

April 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 65 years of age
•on stable doses of insulin (\>/= 40 units/day) alone or with metformin for at least 3 months
•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 TZDs or any other oral antidiabetic (excluding metformin) 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