Trial Information

Summary: A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

Status: Completed

Protocol Number: NP20194

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 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.

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. Target sample size is 18.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Crossover
• Endpoints: Pharmacokinetics/dynamics

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. AUC0-6h of plasma glucose Time frame: Days -1, 6 and 12 2. AUC0-12h of GK Activator (2) and metabolite. Time frame: Days 6 and 12 3. AUC0-tau of glyburide Time frame: Days -1 and 6

Key Secondary Outcomes: 1. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/17/2006

Date Last Updated: 10/16/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:36:24 PM