An Open-label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.

Hoffmann-La Roche0 sites18 target enrollmentOctober 2006

ConditionsDiabetes Mellitus Type 2

InterventionsGK Activator (2)Glyburide

DrugsGK Activator (2)Glyburide

Overview

Phase: Phase 1
Intervention: GK Activator (2)
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 18
Primary Endpoint: AUC0-6h of plasma glucose
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

July 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adult patients, aged 18-75 years;
•type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
•untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.